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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001392 |
The present protocol seeks to advance our understanding of glomerular diseases characterized by progressive glomerulosclerosis in the absence of established immune-mediated renal injury. To this end, we will enroll patients with primary podocytopathies (minimal change nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy) and diabetic nephropathy, as well as patients with the clinical diagnosis (prior to renal biopsy) with one of these conditions. The protocol has three modules, with two consents and two assents. There is no ceiling on patient recruitment for modules 1 and 2. We want to recruit 16 patients for module 3.
Condition |
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AIDS Associated Nephropathy Focal Glomerulosclerosis HIV Infections |
Study Type: | Observational |
Official Title: | Pathogenesis of Glomerulosclerosis |
Study Start Date: | April 1994 |
The present protocol seeks to advance our understanding of glomerular diseases characterized by progressive glomerulosclerosis in the absence of established immune-mediated renal injury. To this end, we will enroll patients with primary podocytopathies (minimal change nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy) and diabetic nephropathy, as well as patients with the clinical diagnosis (prior to renal biopsy) with one of these conditions. The protocol has three modules, with three consents and three assents. There is no ceiling on patient recruitment for modules 1 and 2. We want to recruit 16 patients for module 3.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
InclusionCriteria: children of all ages and adults, including pregnant women, and impaired subjects, all with kidney disease. For pathogenetic studies, we will also include healthy volunteers, including children greater than 12 yrs of age and adults.
Module 2:RESEARCH RENAL BIOPSY
Clinically-indicated renal biopsy, with use of a portion of a second biopsy core for research.
Inclusion Criteria: all adults or children with past renal biopsy which demonstrated a glomerulosclerotic disease or in all adults or children without prior renal biopsy and clinical suspicion of glomerulosclerotic disease.
Exclusion Criteria: Pregnant women.
Clinically-indicated renal biopsy, obtaining a third biopsy core for research purposes.
Inclusion Criteria: all adults with past renal biopsy which demonstrated a glomerulosclerotic disease or in all adult patients without prior renal biopsy and high pre-test likelihood of a glomerulosclerotic disease.
Exclusion Criteria: Pregnant women, patients with a single kidney, impaired subjects, and children less than 18 yr.
Inclusion Criteria: adults with collapsing glomerulopathy.
Exclusion Criteria: Pregnant women, patients with a single kidney, impaired subjects, and children less than 18 yr.
Module 3: RENAL FUNCTION AND STRUCTURE IN LEAN, OVERWEIGHT, AND OBESE YOUNG ADULTS
Inclusion Criteria: young adults aged 18 to 21, including lean young adults with BMI less than 25 kg/m2 and obese young adults with BMI greater than 30 kg/m2. Participants with a history of hyperlipidemias or high fasting glucose will still be eligible for the study as these co-morbidities are often consequence of being obese.
Exclusion Criteria: Young adults with proteinuria (random urine protein to creatinine ratio greater than 0.2, microalbuminuria (spot urine albumin to cretinine ratio greater than 20 mg/g), creatinine clearance less than 80 mL/min/1.73m2, chronic kidney disease, high blood pressure (systolic blood pressure greater than 140 and diastolic blood pressure greater than 90 on 3 blood pressure readings obtained at least one week apart), diabetes, and pregnant women.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 940127, 94-DK-0127 |
Study First Received: | November 3, 1999 |
Last Updated: | September 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00001392 |
Health Authority: | United States: Federal Government |
Retrovirus PCR Renal Failure HIV |
AIDS-Associated Nephropathy Glomerulosclerosis, Focal Segmental Sexually Transmitted Diseases, Viral Glomerulonephritis Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Urologic Diseases |
HIV Infections Nephritis Sexually Transmitted Diseases Kidney Diseases Retroviridae Infections Focal segmental glomerulosclerosis Kidney Failure |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |