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NCT00340678 · ClinicalTrials.gov registry record · Phase 3
Renoprotection in Early Diabetic Nephropathy in Pima Indians
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
NCT00340678 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 170 participants.
The verdict
NCT00340678, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
Study Summary
This investigation is a randomized, double-blinded, placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to test the hypothesis that blockade of the renin-angiotensin system with the angiotensin receptor blocker (ARB) losartan can prevent or further attenuate the development and progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are receiving standard diabetes care. One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist, losartan, or placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and fractional clearances of albumin and IgG will be made initially, at one month, and at 12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in 111 subjects. Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups.
Interventions
- DRUG Placebo
- DRUG Losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 1995-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340678
The ClinicalTrials.gov registry entry for NCT00340678 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00340678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00340678 about?
NCT00340678 is a clinical study titled "Renoprotection in Early Diabetic Nephropathy in Pima Indians". This investigation is a randomized, double-blinded, placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to test the hypothesis that blo...
What is the current status of trial NCT00340678?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 1995-08. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00340678?
The interventions under investigation include: Placebo (DRUG), Losartan (DRUG).
Who is sponsoring clinical trial NCT00340678?
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.
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