NCT01802034

Brief Summary

A central goal of this data repository is to collect data from a large population of subjects with a variety of renal disease states. Cohorts will include subjects with diabetes, inflammatory/autoimmune and transplant related renal conditions. Additionally, the repository will have the capacity to store biospecimens and electronic data in control subjects without established renal disease. This initiative will provide an opportunity to compare data from various disease states and controls with the objective of determining clinical and biological factors that predict disease progression, response to therapy and identify discriminating noninvasive clinical and biological features that predict renal biopsy findings.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2013Aug 2028

Study Start

First participant enrolled

February 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
15.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

15.5 years

First QC Date

February 15, 2013

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in disease progression

    Up to 10 years

Study Arms (3)

Native, Renal Tissue Preservation Group

Subjects who have a renal biopsy and the tissue is possessed and maintained by the RENAL AID repository.

Native, Non-tissue Preservation Group

1. Subjects who have had a renal biopsy but the tissue is not held by RENAL AID repository; and/or 2. Subjects with diabetes and renal disease who have not had a renal biopsy.

Transplant Nephropathy Group

Subjects who have had a renal transplant and require a transplant biopsy for either surveillance or "for-cause" indications.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from The Rogosin Institute, NewYork Presbyterian Hospital and affiliated institutions.

You may qualify if:

  • All Groups:
  • Males or females
  • years of age and older
  • Willing and able to provide informed consent
  • Native Biopsy Tissue Group:
  • \- Require an initial kidney biopsy for medical necessity
  • Native Kidney, Non-tissue Group:
  • Previously had a kidney biopsy and the tissue is not stored in this biorepository; or
  • Have diabetes and kidney disease and have not had a kidney biopsy
  • Allograft Tissue Group:
  • \- Have undergone a renal transplant and require a transplant biopsy for either surveillance or "for-cause" indications.

You may not qualify if:

  • \- Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue

MeSH Terms

Conditions

Kidney DiseasesKidney Failure, ChronicDiabetic NephropathiesLupus NephritisGlomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlomerulonephritisNephritisLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alan S Perlman, M.D.

    The Rogosin Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelson Chen, M.A.

CONTACT

Alan Perlman, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations