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NCT00001392 · ClinicalTrials.gov registry record
Pathogenesis of Glomerulosclerosis
A clinical trial of Glomerular Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 537
- Enrollment target
- 1
- Study location
NCT00001392 is a study of Glomerular Disease that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 537 participants, above the 168-participant average among 4 other Glomerular Disease trials with a reported enrollment target (220% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00001392, a study of Glomerular Disease, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 537 participants
- Enrollment target
- 1
- Study location
Study Summary
The present protocol seeks to advance our understanding of sclerosing glomerular and tubulointerstitial kidney diseases, including but not limited to variants of focal segmental glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This protocol will encompass studies of the natural history, pathogenesis and treatment of these chronic kidney disorders. It will also allow us to: (1) provide second opinions to referring physicians about management of subjects with these relatively rare kidney diseases; (2) collect research samples (e.g., blood), urine, and kidney tissue obtained from clinically-indicated or from research renal biopsies); (3) and treat these subjects with standard or other approved therapies; or (4) invite selected subjects patients to participate in limited pilot studies of novel combinations of standard therapeutic agents, such as rituximab and cyclosporine. (5) Agricultural worker chronic kidney disease of undetermined etiology (CKDu) is a growing problem in tropical countries in the Americas and Asia, including Sri Lanka where collaborators are located. We will receive kidney tissue from 25 CKDu cases for pathologic examination and transcriptional profiling and blood, plasma, serum, urine for metabolomic and genetic analysis from 50 cases and controls. Subjects were consented and samples were collected under a protocol approved by the University of Colombo IRB. These studies may provide the opportunity to generate new hypotheses regarding pathogenesis and treatment that would be candidates for testing in other research protocols. Subjects with known or suspected forms of sclerosing glomerular or chronic, fibrosing tubulointerstitial kidney diseases will undergo routine medical evaluation, laboratory testing, imaging procedures and kidney biopsies as medically indicated. Selected subjects will be invited to provide informed consent to undergo a kidney biopsy for research purposes. Blood, urine, and tissue samples will be
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 1996-04-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001392
The ClinicalTrials.gov registry entry for NCT00001392 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 537 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 168-participant average among 4 other Glomerular Disease trials with a reported enrollment target (220% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glomerular Disease appearing as the primary indexed condition, and to 0 interventions.
NCT00001392 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001392 about?
NCT00001392 is a clinical study titled "Pathogenesis of Glomerulosclerosis". The present protocol seeks to advance our understanding of sclerosing glomerular and tubulointerstitial kidney diseases, including but not limited to variants of focal segmental glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This protocol will encompass studies of t...
What is the current status of trial NCT00001392?
This trial is currently completed. The enrollment target is 537 participants. The study started on 1996-04-16.
What conditions does trial NCT00001392 study?
This clinical trial studies the following conditions: Glomerular Disease.
Who is sponsoring clinical trial NCT00001392?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001392 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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