Recruiting

Observational StudyNephrotic Syndrome Study Network

Sponsor:

University of Michigan

Code:

NCT01209000

Conditions

Minimal Change Disease (MCD)

Membranous Nephropathy

Glomerulosclerosis, Focal Segmental

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Kidney Biopsy

Study Details

Brief summary:

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.

Conditions

Minimal Change Disease (MCD)

Membranous Nephropathy

Glomerulosclerosis, Focal Segmental

Study ID

NCT01209000

Start date

Apr, 2010

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Cohort A (biopsy cohort) Inclusion Criteria:

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)

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

FSGS/MCD Cohort (Cohort A)

Focal Segmental Glomerulosclerosis/Minimal Change Disease (FSGS/MCD) Cohort

Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for FSGS or MCD.

Eligible participants must be scheduled for a clinically indicated renal biopsy.

MN Cohort (Cohort A)

Membranous Nephropathy (MN) Cohort

Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for MN.

Eligible participants must be scheduled for a clinically indicated renal biopsy.

Other glomerulopathies cohort

Participants enrolled in NEPTUNE and determined to not have FSGS/MCD or MN will be followed in a third group.

Eligible participants must be scheduled for a clinically indicated renal biopsy.

cNEPTUNE (Cohort B)

Participants < 19 years of age, with < 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.

Interventions

Kidney Biopsy

Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.

Primary outcome measure

Event rate of change in urinary protein excretion and renal function. [ Time Frame: 60 months ]
Rate of change in renal function. [ Time Frame: 60 months ]

Central Contacts and Locations

Central contacts

Chrysta C. Lienczewski, BS

734-615-5021 NEPTUNE-Study@umich.edu

Amanda Williams, BS

734-615-5017 NEPTUNE-Study@umich.edu

Locations

University of Southern California-Children's Hospital

Recruiting

Los Angeles, California, United States, 90227

Contacts

Sharon Tang, BSN

323-361-7299 shatang@chla.usc.edu

Principal Investigator:

Kevin Lemley, MD, PhD

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kshama Mehta, PhD

650-736-1822 krmehta@stanford.edu

Principal Investigator:

Richard Lafayette, MD

Lundquist Biomedical Research Institute at Harbor UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Contacts

Janine LaPage

310-222-4104 jlapage@labiomed.org

Principal Investigator:

Sharon Adler, MD

University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Carlos Bidot

305-243-8973 cbidot2@miami.edu

Principal Investigator:

Alessia Fornoni, MD. PhD

Emory University and Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Emily Yun

404-712-9998 emily.yun@emory.edu

Principal Investigator:

Laurence Greenbaum, MD, PhD

John Stroger Cook County Hospital

Recruiting

Chicago, Illinois, United States, 60680

Contacts

Mathew Itteera

312-864-4614 mitteera@cookcountyhhs.org

Principal Investigator:

Ambarish Athavale, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Catherine Creed

ccreed@kumc.edu

Principal Investigator:

Ellen McCarthy, MD

Johns Hopkins Medical Institute

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sara Boynton

443-287-9051 sboynto3@jhmi.edu

Principal Investigator:

Alicia Neu, MD

CS Mott Children's Hospital, University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Hailey Desmond, MS

734-232-4851 heturner@umich.edu

University of Michigan Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Chrysta C. Lienczewski, BS - adult

734-615-5021 boridley@med.umich.edu

Amanda Williams, BS - adult

734-615-5017 amwi@umich.edu

Principal Investigator:

Matthias Kretzler, MD

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Kelsey Markus

kemarkus@cmh.edu

Principal Investigator:

Tarak Srivastava, MD

Cohen Children's Hospital

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Suzanne Vento, BSN

718-470-3499 svento@northwell.edu

Principal Investigator:

Christine Sethna, MD

New York University Medical Center

Recruiting

New York, New York, United States, 10010

Contacts

Frank Modersitzki, MPH - adult

212-686-7500 Frank.Modersitzki@va.gov

Laura Jane Pehrson - peds

laurajane.pehrson@nyulangone.org

Principal Investigator:

Olga Zhadnova, MD

Bellevue Hospital

Recruiting

New York, New York, United States, 10016

Contacts

Frank Modersitzki, MPH

212-686-7500 Frank.Modersitzki@va.gov

Principal Investigator:

Laura Barisoni, MD

New York University Veterans Administration

Recruiting

New York, New York, United States, 10016

Contacts

Frank Modersitzki, MPH

212-686-7500 Frank.Modersitzki@va.gov

Principal Investigator:

Laura Barisoni, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Anup Pradhan

212-305-6842 arp2209@cumc.columbia.edu

Principal Investigator:

Andrew Bomback, MD, MPH

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 11040

Contacts

Patti Flynn, RN

718-655-1120 pflynn@montefiore.org

Principal Investigator:

Frederick Kaskel, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Anne Froment

919-923-1382 Anne_Froment@med.unc.edu

Fernanda Ochoa

ferochoa@email.unc.edu

Principal Investigator:

Patrick H. Nachman, MD

Atrium Health Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Layla Lo

nkauj.lo@atriumhealth.org

Principal Investigator:

Susan Massengill, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Stefanie Larson

larsons2@ccf.org

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Alexander Price

alexander.price2@osumc.edu

Principal Investigator:

Salem Almaani, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alilya Edwards

EdwardsA1@chop.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Krishna Kallem, MD - adult, MS

484-358-0315 krishna.kallem@uphs.upenn.edu

Aliya Edwards - peds

EdwardsA1@chop.edu

Principal Investigator:

Lawrence Holzman, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Zoe Pfeffer, BS

215-707-4712 zoe.pfeffer@tuhs.temple.edu

Principal Investigator:

Crystal Gadegbeku, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

David Selewski, MD, MS

University of Texas-Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Elizabeth Robles

elizabeth.robles@utsouthwestern.edu

Principal Investigator:

Kamal Sambandam, MD

Texas Children's Hospital - Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Aisha Deslandes

aisha.deslandes@bcm.edu

Principal Investigator:

Shweta S. Shah, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98145

Contacts

Emily Pao

emily.pao@seattlechildrens.org

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Linda Manahan, BSN

lmanahan@nephrology.washington.edu

Principal Investigator:

Peter J. Nelson, MD

Providence Medical Research Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

Ann Cooper, CCRC

509-474-4327 Ann.Cooper@providence.org

Kelli Kuykendall, CCRC

509-474-4320 Kelli.Kuykendall@providence.org

Credit Valley Hospital

Recruiting

Toronto, Ontario, Canada, L5M 2N1

Contacts

Martin Romano, MD

416-340-3514 martin.romano@thp.ca

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rhea O'Neill

rhea.oneill@sri.utoronto.ca

Principal Investigator:

Michelle Hladunewich, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Paul Ling, MD

416-340-3514 pling@uhnresearch.ca

Martin Romano, MD

Martin.Romano@trilliumhealthpartners.ca

Principal Investigator:

Daniel Cattran, MD

More Information

Sponsor

University of Michigan

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

Focal and Segmental Glomerulosclerosis
Focal & Segmental Glomerulosclerosis
Focal Segmental Glomerulosclerosis
FSGS
Minimal change disease
MCD
Membranous Nephropathy
MN
Nephrotic Syndrome
Neph Syndrome
NEPTUNE
NephCure
Halpin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-10.