Status:
ACTIVE_NOT_RECRUITING
SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins University
Conditions:
Renal Insufficiency, Chronic
Eligibility:
All Genders
21-79 years
Brief Summary
Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage...
Detailed Description
Study Visits and Participant Contact During its 5th and final phase, the 7 Clinical Centers comprised of 12 sites will extend participant follow-up for participants who have not reached ESKD before t...
Eligibility Criteria
Inclusion
- During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:
- Age Range: 21 - 79 years
- Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
- Proteinuria: varies dependent on eGRF
Exclusion
- Unable or unwilling to provide informed consent
- Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month
- Prior organ or bone marrow transplant
- Prior renal transplant
- Received immunosuppressive or other immunotherapy for primary renal disease or systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA nephropathy, cryoglobulin, etc.) within the past six months before enrollment
- Received chemotherapy or alkylating agents for systemic cancer
- Known cirrhosis
- NYHA Class III or IV heart failure at baseline
- Previous diagnosis of multiple myeloma or renal carcinoma
- Previously diagnosed polycystic kidney disease
- Known HIV infection and/or AIDS
- Pregnant or breast-feeding women
- Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes).
- Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident)
- Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
5499 Patients enrolled
Trial Details
Trial ID
NCT00304148
Start Date
July 1 2003
End Date
June 1 2028
Last Update
November 13 2025
Active Locations (12)
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1
Kaiser Permanente of Northern California
Oakland, California, United States, 94612
2
University of California
San Francisco, California, United States, 94143-0532
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
4
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112