Protocol Number: 94-DK-0127

Title:

Pathogenesis of Glomerulosclerosis

Number:

94-DK-0127

Summary:

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.

1) 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.

2) 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.

3) 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.

Sponsoring Institute:

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

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS

Enrollment criteria:

Inclusion: For evaluation, treatment, and pathogenic studies, we will include 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.

Exclusion: none

RESEARCH RENAL BIOPSY

Enrollment criteria:

1) Clinically-indicated renal biopsy, with use of a portion of a second biopsy core for research.

Inclusion: 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. The number of passes with the biopsy needle will be the same number of passes required to obtain sufficient tissue for clinical diagnostic purposes.

Exclusion: Pregnant women (NIH biopsy protocol involves CT with radiation exposure).

2) Clinically-indicated renal biopsy, obtaining a third biopsy core for research purposes.

Inclusion: 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. We will offer options 1 (above) and 2 (this one) to all qualifying subjects; those subjects who are not willing to accept additional risk will select 1 and others may accept 2.

Exclusion: Pregnant women, patients with a single kidney, impaired subjects, and children less than 18 yr.

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

Inclusion: adults with collapsing glomerulopathy.

Exclusion: Pregnant women, patients with a single kidney, impaired subjects, and children less than 18 yr.

Special Instructions:

Currently Not Provided

Keywords:

Retrovirus

PCR

Renal Failure

HIV

Recruitment Keyword(s):

None

Condition(s):

AIDS Associated Nephropathy

Focal Glomerulosclerosis

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Associated focal and segmental glomerulosclerosis in the acquired immunodeficiency syndrome

The nephropathology in human immunodeficiency virus infection

Histopathological changes in simian immunodeficiency virus infection

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