Search Results
within category "Kidney & Urinary System"
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EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients Who Have Been Incompletely Treated With BCG or Are BCG-Naïve (LEGEND STUDY)
This open-label, multicenter study will evaluate the safety and efficacy of intravesical
administration of EG-70 and its effect on bladder tumors in patients with NMIBC who have
failed BCG therapy and are recommended for radical cystectomy or high-risk NMIBC patients who
are BCG-naïve or have received incomplete BCG treatment. This study study consists of two
phases, a dose-escalation Phase (Phase 1) to establish safety and recommended phase 2 dose
(RP2D), followed by a Phase 2 efficacy study at the RP2D to establish efficacy. Eligible
BCG-unresponsive NMIBC patients will be enrolled in Phase 1, and Cohort 1 of Phase 2.
Eligible high-risk NMIBC patients who have been incompletely treated or are BCG-naïve will be
enrolled starting in Phase 2 in a separate single-arm cohort (Cohort 2).
BCG-unresponsive Patients:
1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without resected papillary
tumors who are indicated for, ineligible for, or have elected not to undergo
cystectomy:
1. persistent high-grade disease (Ta, T1, or Tis) after receiving at least one
induction course of intravesical BCG (at least 5 of 6 induction doses) or
recurrence after 12 months of receiving at least one induction course of
intravesical BCG (at least 5 of 6 induction doses), or
2. T1 high grade disease residual at the first evaluation following induction BCG
(at least 5 of 6 doses).
BCG-Naïve or BCG-incompletely treated Patients (Phase 2 Only):
2. NMIBC with CIS with or without resected papillary tumors who are indicated for,
ineligible for, or have elected not to undergo cystectomy:
1. persistent high-grade disease (Ta, T1, or Tis) or recurrence within 6 months of
receiving at least 1 dose, but not the full course, of intravesical BCG, or
2. high-grade disease (Ta, T1, or Tis) who have not yet received any treatment with
BCG, or
3. T1 high grade disease residual at the first evaluation following incomplete
treatment with BCG
3. Patients who have previously been treated with at least one dose of intravesical
chemotherapy at TURBT are eligible for inclusion one month post-treatment.
All Patients:
4. Patients who have previously been treated with an investigational or approved
checkpoint inhibitor (e.g., pembrolizumab) and failed treatment are eligible for
inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2).
5. Male or non-pregnant, non-lactating female, 18 years or older.
6. Women of childbearing potential must have a negative pregnancy test at Screening. A
female patient is considered to be of child-producing potential unless she:
1. has had a hysterectomy or bilateral oophorectomy or
2. is age ≥ 60 years and is amenorrhoeic or
3. is age < 60 years and has been amenorrhoeic for ≥ 12 months (including no
irregular menses or spotting) in the absence of any medication which induces a
menopausal state and has documented ovarian failure by serum oestradiol and
follicle-stimulating hormone levels within the institutional laboratory
postmenopausal range).
7. All patients of childbearing potential must be willing to consent to using effective
double-barrier contraception, i.e., intrauterine device, birth control pills,
depo-provera, and condoms while on treatment and for 3 months after their
participation in the study ends.
8. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0, 1, and 2.
9. Hematologic inclusion within 2 weeks of start of treatment:
1. Absolute neutrophil count >1,500/mm3.
2. Hemoglobin >9.0 g/dl.
3. Platelet count >100,000/mm3.
10. Hepatic inclusion within 2 weeks of Day 1:
1. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN).
2. Adequate renal function with creatinine clearance >30 mL/min (measured using
Cockcroft-Gault equation or the estimated glomerular filtration rate from the
Modification of Diet in Renal Disease Study).
3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
for the institution, alkaline phosphatase ≤2.5 x ULN for the institution, unless
bone metastasis is present in the absence of liver metastasis.
11. Prothrombin time and partial thromboplastin time within the normal limits at
Screening.
12. Must have satisfactory bladder function with ability to retain study drug for a
minimum of 60 minutes.
13. Patient or legally authorized representative (LAR) must be willing and able to comply
with all protocol requirements.
14. Patient or LAR must be willing and able to give informed consent and any
authorizations required by local law for participation in the study.
Exclusion Criteria:
1. Any other malignancy diagnosed within 1 year of study entry (except basal or squamous
cell skin cancers or noninvasive cancer of the cervix) is excluded.
2. Concurrent treatment with any chemotherapeutic agent.
3. Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to
Screening.
4. Treatment with last therapeutic agent within 30 days of Screening (Phase 1 and Phase
2) or treatment with an investigational checkpoint inhibitor within 3 months of
Screening (Phase 2 only).
5. History of vesicoureteral reflux or an indwelling urinary stent.
6. Participation in any other research protocol involving administration of an
investigational agent within 1 month prior to Day 1.
7. History of external beam radiation to the pelvis at any time or prostate brachytherapy
within the last 12 months.
8. History of interstitial lung disease and/or pneumonitis in patients who have
previously received a PD-1 or PD-L1 inhibitor therapy.
9. Evidence of metastatic disease.
10. History of difficult catheterization that in the opinion of the Investigator will
prevent administration of EG-70.
11. History of interstitial cystitis.
12. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy.
13. Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.
14. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial
infarction within 6 months).
Cancer and Blood Pressure Management, CARISMA Study
This phase II trial studies how well intensive blood pressure management works in decreasing
systolic blood pressure in patients with kidney or thyroid cancer that has spread to other
places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor
cancer therapy. This study is being done to find out if a systolic blood pressure to a target
of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well
tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg
while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors
understand the best way to control blood pressure in kidney or thyroid cancer patients taking
anti-angiogenic tyrosine kinase inhibitor.
• English speaking
• Patient must have histologically or cytologically-proven advanced metastatic renal
cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic
tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib,
cabozantinib, lenvatinib, vandetanib, or axitinib)
• NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then
alternative non-sulfa medications can be considered in consultation with the
C-BAC. Patient with a noted severe allergic reactions to medications listed in
the algorithms is not necessarily excluded from this trial, as alternative
medications could be considered in consultation with the C-BAC. Moreover, the
patient treated with pre-existing medications that may interact with proposed BP
medications is not necessarily excluded, as alternative medications exist. The
clinical significance of any potential drug interactions can also be addressed
with the C-BAC.
• Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with
immunotherapy is also permissible
• Patient must have either clinical cardiovascular (CV) disease or evidence of increased
CV risk as defined by one or more of the following:
• Clinical CV disease (history of myocardial infarction [MI] acute coronary
syndrome, coronary revascularization, carotid endarterectomy or stenting greater
than 3 months prior to registration, peripheral artery disease, cerebrovascular
accident greater than 3 months prior to registration, abdominal aortic aneurysm
or heart failure [HF])
• An American College of Cardiology/American Heart Association (ACC/AHA) CV risk
score of at least 10%
• Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR]
between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an
eGFR < 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to
the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
• Patient must have systolic blood pressure (SBP) >= 130 mmHg on two or more occasions
according to any in-clinic visit in the 12 weeks prior to or during their initial 4
weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension
or on pre-existing anti-hypertensive medications are eligible for enrollment. However,
patient must not be on more than 3 baseline blood pressure medications at time of
entry
• NOTE: If a patient has a single elevated SBP >= 130mmHg but not on repeat
assessment, an additional SBP assessment should be performed to confirm
ineligibility
• Patient must agree to comply with performing home blood pressure monitoring using an
Omron7250 oscillometric monitor at home, or equivalent models
• Women of childbearing potential and sexually active males must be strongly advised to
use accepted and effective methods of contraception or to abstain from sexual
intercourse for the duration of their participation in the study
• Patient must have internet access through a computer, tablet, or smart phone to use
EASEE-PRO and home BP monitoring. A valid phone number to receive text messages and
email address are also necessary
• Leukocytes >= 3,000/mcL (obtained within 14 days prior to registration)
• Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to registration)
• Platelets >= 100,000/mcL (obtained within 14 days prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to
registration)
• Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated
• Patient with a history of hepatitis C virus (HCV) infection must have been treated and
cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
• Patient with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression
• Patient with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are eligible if the treating physician determines that
immediate CNS specific treatment is not required and is unlikely to be required during
the first cycle of therapy
• Patient with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
• Patient must not have end-stage renal failure on dialysis, history of repeated
hyperkalemia with a potassium > 5.5 mEq/l, or have a kidney transplant, or an eGFR <
30 ml/min/1.73 m^2
• Patient must not have coronary artery bypass grafting, MI acute coronary syndrome
severe/unstable angina, stroke, transient ischemic attack, clinically significant
bleeding requiring hospitalization or pulmonary embolism within 3 months prior to
registration
• Patient must not have brain surgery or radiotherapy within 2 weeks prior to
registration
• Patient must not have uncontrolled blood pressure defined by SBP > 160 mmHg on three
or more antihypertensives prior to TKI initiation
• Patient with an arm circumference too large (> 50 cm) or small (< 17 cm) to allow
accurate BP measurement with available devices will not be eligible
• Women must not be pregnant or breast-feeding due to the potential harm to an unborn
fetus and possible risk for adverse events in nursing infants with some
anti-hypertensives, including angiotensin receptor blockers. All females of
childbearing potential must have a blood test or urine study within 14 days prior to
registration to rule out pregnancy. A female of childbearing potential is defined as
any woman, regardless of sexual orientation or whether they have undergone tubal
ligation, who meets the following criteria: has achieved menarche at some point, has
not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally
postmenopausal (amenorrhea following cancer therapy does not rule out childbearing
potential) for at least 24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months)
A Study of ZN-c3 in Participants With Solid Tumors
This is a Phase 1/2 open-label, multicenter study, evaluating the safety, tolerability,
efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3 alone and in combination with
other drugs.
In order to be eligible to participate in any phase of this study, an individual must meet
all of the following criteria:
1. Provision of written informed consent.
2. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of
informed consent.
3. Adequate hematologic and organ function as defined by the following criteria:
1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; excluding measurements obtained
within 7 days after daily administration of filgrastim/sargramostim or within 3
weeks after administration of pegfilgrastim.
2. Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days
after transfusion of platelets.
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper
limit of normal (ULN). If liver function abnormalities are due to underlying
liver metastases, AST and ALT ≤ 5 x ULN.
4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
4. Female subjects of childbearing potential must have a negative serum beta human
chorionic gonadotropin test.
5. Male subjects and female subjects of childbearing potential must agree to use an
effective method of contraception per institutional standard prior to the first dose
and for 90 days after the last dose of ZN-c3.
Individuals must meet the additional criteria in order to be eligible to participate in
Phase 1:
1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
2. Measurable or evaluable disease per RECIST version 1.1.
Individuals must meet these additional criteria in order to be eligible to participate in
Phase 2 Single Agent part of the study:
1. ECOG performance status ≤ 1.
2. Measurable disease per RECIST version 1.1.
Individuals must meet these additional criteria in order to be eligible to participate in
Phase 2 combination with a PARP inhibitor:
1. ECOG performance status ≤ 1.
2. Measurable disease per RECIST version 1.1.
Individuals must meet these additional criteria in order to be eligible to participate in
Phase 2 combination with a PD-1 inhibitor:
1. ECOG performance status ≤ 1.
2. Measurable disease per RECIST version 1.1.
Key
Exclusion Criteria:
1. Any of the following treatment interventions within the specified time frame prior to
Cycle 1 Day 1:
1. Major surgery within 28 days.
2. Radiation therapy within 21 days.
3. Any prior systemic therapy regardless of the stop date, but the subject must have
recovered to eligibility levels from prior toxicity.
4. Autologous or allogeneic stem cell transplant within 3 months.
5. Current use of an investigational agent that is not expected to be cleared by the
first dosing of study drug or that has demonstrated to have prolonged side
effects. Subjects should have recovered from the side effects to a Grade 0 or 1
(except alopecia).
2. A serious illness or medical condition(s) including, but not limited to, the
following:
1. Brain metastases that require immediate treatment or are clinically or
radiologically unstable.
2. Leptomeningeal disease that requires or is anticipated to require immediate
treatment.
3. Myocardial impairment of any cause resulting in heart failure by New York Heart
Association Criteria Class III or IV.
4. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
study drug administration, or may interfere with the interpretation of study
results, and in the judgment of the Investigator would make the subject
inappropriate for entry into this study.
5. Significant gastrointestinal abnormalities
6. Active or uncontrolled infection.
3. Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade 2
neuropathy, alopecia or skin pigmentation).
4. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in
class.
5. Subjects with active (uncontrolled, metastatic) second malignancies or requiring
therapy.
Drug: ZN-c3
Small Cell Lung Cancer, Fallopian Tube Cancer, Non Small Cell Lung Cancer, Malignant Melanoma, Metastatic Breast Cancer, Triple Negative Breast Cancer, Epithelial Ovarian Cancer, Urothelial Carcinoma, Solid Tumor, Corpus Uteri, Peritoneal Cancer
• Histologically or cytologically documented locally advanced or metastatic solid tumor
malignancy.
• Progressed or was intolerant to all available therapies known to confer clinical
benefit appropriate for their tumor type, and for which the patient was eligible and
willing to receive, or refused SOC treatments that are perceived to have marginal
clinical benefit.
• Adequate bone marrow, kidney and liver function.
• Performance status of 0 or 1.
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
except for AEs not constituting a safety risk by Investigator judgement.
Exclusion Criteria:
• Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
Drug: NGM707, Drug: NGM707 plus pembrolizumab, Drug: NGM707, Drug: NGM707, Drug: NGM707, Drug: NGM707 plus pembrolizumab, Drug: NGM707 plus pembrolizumab
Esophageal Cancer, Breast Cancer, Melanoma, Gastric Cancer, Colorectal Cancer, Ovarian Cancer, Glioblastoma, Cervical Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Mesothelioma, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Brain and Nervous System, Breast - Female, Breast - Male, Kidney, Liver, Lung/Thoracic, Melanoma, skin, Other Digestive Organ, Other Skin, Ovary, Pancreas, Squamous Cell Carcinoma of Head and Neck, Endocervical Cancer
Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet
The purpose of this study is to compare over the counter and alternative prescription urinary
alkalinizing agents to slow release potassium citrate in their ability to modify urinary
parameters associated with stone formation.
• Adults aged 18 and older.
• with or without a history of stone disease.
Exclusion Criteria:
• They are unable to take any of the medications due to health reasons.
• Participants are pregnant or nursing.
• Participants are unable to adhere to the metabolic diet.
• Participants had a prior adverse event from one or more of the medications.
Pediatric KIDney Stone (PKIDS) Care Improvement Network (PKIDS)
The goals of this study are to improve the ability of pediatric patients and their caregivers
to select surgical treatment options for kidney stones and to enable urologists to use
techniques that result in the best outcomes for these surgeries.
1. Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the
removal of at least one kidney and/or ureteral stone.
2. Parental/guardian or participant (if ≥ 18 years old) permission (informed consent),
and if appropriate, child assent
2a. Individuals who are not able to provide consent/assent (whether ≥18 or < 18 years)
and/or not willing or able to complete questionnaires are eligible for participation for
the stone clearance assessment and Electronic Health Record (EHR) surveillance if the legal
guardian consents for study participation.
2b. Individuals for whom native-language questionnaires are not available can also
participate in stone clearance assessment and EHR surveillance.
Exclusion Criteria:
1. Patients for whom conducting informed consent and baseline study procedures would
confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency
surgery) and delay necessary immediate clinical care.
2. Parent/guardians or patients, who, in the opinion of the Investigator, may be
non-compliant with study schedules or procedures
Pathophysiology of Uric Acid Nephrolithiasis (IUAN)
This study has two aims:
Aim 1: To determine the presence of accumulation of fat within cells and the functional
consequences of this in the kidney by correlating kidney fat content with urine test results.
Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on
excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone
formation in subjects with uric acid stones.
Pioglitazone is already U.S. Food & Drug Administration (FDA)-approved for the treatment of
type 2 diabetes, but is not approved by the FDA for treating or preventing or diagnosing
stone risk.
• Subjects with uric acid kidney stone disease
• Age > 21 years
Exclusion Criteria:
• Body weight> 350 lb
• Chronic alcohol use
• Chronic liver disease
• Chronic renal disease
• Anemia
• Contraindication to pioglitazone use:
• history of congestive heart failure NYHA class III or IV
• significant pedal edema
• liver failure
• not willing to practice an effective contraception for the duration of the study
• Thiazolidinedione use in the preceding 18 months
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) (ProActive)
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing
clinical care for patients receiving physician ordered Prospera, an allograft rejection test,
and a historical control arm collecting data on cases at the same sites whose kidney
allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular
Filtration Rate eGFR. This registry will compare patient management and outcomes in patients
who receive Prospera (Prospera arm) to the outcomes of the historical control group (control
arm) to determine Prospera's clinical utility. High-risk subjects defined as having a
biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA
with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies
cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm
and historical control arm.
Inclusion Criteria Prospera Arm:
1. 18 years of age or older
2. Renal allograft (kidney transplant) up to 2 years prior to signing informed consent.
Newly transplanted patients to receive Prospera testing within 60 days of transplant
3. A genetically different donor (not an identical twin)
4. Selected by a healthcare provider to receive Prospera dd-cfDNA test according to the
regular interval testing schedule as part of their practical care
5. Able to read, understand and provide written informed consent
6. Willing and able to comply with the study visit schedule and study requirements
Exclusion Criteria Prospera Arm:
1. Pregnant
2. Routine ongoing testing with another dd-cfDNA or RNA biomarker test after enrollment
into the ProActive study. Receipt of another dd-cfDNA test within 30 days of a patient
being enrolled in the study.
3. History of another organ transplant (i.e. aside from renal allograph)
4. A serious medical condition that may adversely affect ability to participate in the
study (e.g, dementia, current diagnosis of cancer)
5. Previously enrolled in the ProActive Registry, with the exception of a graft failure
and a new renal allograft
Inclusion Criteria Control Arm:
1. 18 years of age or older at the time of transplant
2. Had a renal allograft
3. Had a genetically different donor
4. Had a minimum of three evaluations per year during the three years since the renal
allograft or until allograft failure
Exclusion Criteria Control Arm:
1. Female patients who were pregnant at any time during the 3-year historical control
data collection period
2. Had a transplanted organ other than kidney
3. Received results from a dd-cfDNA test designed to assess renal allograft rejection
during the historical control data collection period
Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous
nephropathy (MN), generate an enormous individual and societal financial burden, accounting
for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual
cost in the US of more than $3 billion. However, the clinical classification of these
diseases is widely believed to be inadequate by the scientific community. Given the poor
understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies
are imperfect. The therapies lack a clear biological basis, and as many families have
experienced, they are often not beneficial, and in fact may be significantly toxic. Given
these observations, it is essential that research be conducted that address these serious
obstacles to effectively caring for patients.
In response to a request for applications by the National Institutes of Health, Office of
Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a
number of affiliated universities joined together with The NephCure Foundation the NIDDK,
the ORDR, and the University of Michigan in collaboration towards the establishment of a
Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.
Through this consortium the investigators hope to understand the fundamental biology of
these rare diseases and aim to bank long-term observational data and corresponding
biological specimens for researchers to access and further enrich.
Patients presenting with an incipient clinical diagnosis for FSGS/MCD or MN or pediatric
participants not previously biopsied, with a clinical diagnosis for FSGS/MCD or MN meeting
the following inclusion criteria:
• Documented urinary protein excretion ≥1500 mg/24 hours or spot protein: creatinine
ratio equivalent at the time of diagnosis or within 3 months of the
screening/eligibility visit.
• Scheduled renal biopsy
Cohort B (non-biopsy, cNEPTUNE)
Inclusion Criteria:
• Age <19 years of age
• Initial presentation with <30 days immunosuppression therapy
• Proteinuria/nephrotic
• UA>2+ and edema OR
• UA>2+ and serum albumin <3 OR
• UPC > 2g/g and serum albumin <3
Exclusion Criteria (Cohort A&B):
• Prior solid organ transplant
• A clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• Clinical, serological or histological evidence of systemic lupus erythematosus (SLE)
as defined by the ARA criteria. Patients with membranous in combination with SLE will
be excluded because this entity is well defined within the International Society of
Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently
overlaps with other classification categories of SLE nephritis (68)
• Clinical or histological evidence of other renal diseases (Alport, Nail Patella,
Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas),
genito-urinary malformations with vesico-urethral reflux or renal dysplasia)
• Known systemic disease diagnosis at time of enrollment with a life expectancy less
than 6 months
• Unwillingness or inability to give a comprehensive informed consent
• Unwillingness to comply with study procedures and visit schedule
• Institutionalized individuals (e.g., prisoners)
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™
(TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition
subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical
suspicion of acute rejection. Data collection for the primary objective extends over a 2-year
period.
• Written informed consent and HIPAA authorization;
• At least 18 years of age;
• Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
• At least 3-months post-transplant;
• Stable serum creatinine (per Principal Investigator);
• Treated with any immunosuppressive regimen, and;
• Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of
post-transplant care; and
Exclusion Criteria:
• Recipient of a combined organ transplant with an extra-renal organ and/or islet cell
transplant;
• Recipient of a previous non-renal solid organ and/or islet cell transplant;
• Known to be pregnant;
• Known to be infected with HIV;
• Known to have Active BK nephropathy;
• Known to have nephrotic proteinuria (Per Principal Investigator);
• Participation in other biomarker studies testing clinical utility.
Diagnostic Test: Patients monitored with TruGraf and TRAC testing