Cause of Focal Segmental Glomerulosclerosis - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001392

Purpose

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.

EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS: This protocol will serve as a screening protocol for specific treatment protocols. It will also allow us to provide second opinions about selected glomerular diseases, to collect research samples (blood, urine, and archival kidney tissue) and treat selected patients with renal disease using standard therapy. These studies will allow us to test particular hypotheses and may provide the opportunity to generate new hypotheses that could be tested in other protocols.
RESEARCH RENAL BIOPSY IN PATIENTS WITH GLOMERULOSCLEROSIS: We will carry out renal biopsy for research purposes (limited to previously-diagnosed collapsing glomerulopathy) or to obtain additional renal tissue for research from a biopsy performed for clinical indications (includes diagnosed or suspected minimal change nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy, diffuse mesangial sclerosis, and diabetic nephropathy). This tissue will be used for studies of the podocyte transcriptome, and other glomerular and tubular processes, and for studies to identify viral causes of primary podocyte diseases.
Obesity-Associated Kidney Disease. We will collaborate with Dr. Mona Khurana in studies of lean and obese young adults carried out at Children's National Medical Center. We will assist her in the measurements of iothalamate and para-aminnohippurate clearance, in order to determine glomerular filtration rate and renal plasma flow.

Condition
AIDS Associated Nephropathy Focal Glomerulosclerosis HIV Infections

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Official Title:	Pathogenesis of Glomerulosclerosis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date:

April 1994

Detailed Description:

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.

EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS: This protocol will serve as a screening protocol for specific treatment protocols. It will also allow us to provide second opinions about selected glomerular diseases, to collect research samples (blood, urine, and archival kidney tissue) and treat selected patients with renal disease using standard therapy. These studies will allow us to test particular hypotheses and may provide the opportunity to generate new hypotheses that could be tested in other protocols.
RESEARCH RENAL BIOPSY IN PATIENTS WITH GLOMERULOSCLEROSIS: We will carry out renal biopsy for research purposes (limited to previously-diagnosed collapsing glomerulopathy) or to obtain additional renal tissue for research from a biopsy performed for clinical indications (includes diagnosed or suspected minimal change nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy, diffuse mesangial sclerosis, and diabetic nephropathy). This tissue will be used for studies of the podocyte transcriptome, and other glomerular and tubular processes, and for studies to identify viral causes of primary podocyte diseases.
OBESITY-ASSOCIATE KIDNEY DISEASE. We will collaborate with Dr. Mona Khurana in studies of lean and obese young adults carried out at Children's National Medical Center. We will assist her in the measurements of iothalamate and para-aminnohippurate clearance, in order to determine glomerular filtration rate and renal plasma flow.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Module 1:EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS

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.
Research renal biopsy, performed largely or exclusively for research purposes.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001392

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Rao TK, Filippone EJ, Nicastri AD, Landesman SH, Frank E, Chen CK, Friedman EA. Associated focal and segmental glomerulosclerosis in the acquired immunodeficiency syndrome. N Engl J Med. 1984 Mar 15;310(11):669-73.

Poli A, Abramo F, Taccini E, Guidi G, Barsotti P, Bendinelli M, Malvaldi G. Renal involvement in feline immunodeficiency virus infection: a clinicopathological study. Nephron. 1993;64(2):282-8.

Baskerville A, Ramsay A, Cranage MP, Cook N, Cook RW, Dennis MJ, Greenaway PJ, Kitchin PA, Stott EJ. Histopathological changes in simian immunodeficiency virus infection. J Pathol. 1990 Sep;162(1):67-75.

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

Keywords provided by National Institutes of Health Clinical Center (CC):

Retrovirus
PCR
Renal Failure
HIV

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 30, 2009