Status:
COMPLETED
Delaying the Progression of Diabetic Nephropathy in Pima Indians
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18-65 years
Brief Summary
A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the progression of re...
Detailed Description
A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the progression of re...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible for participation in the study, subjects must meet the following criteria:
- Previous completion of the DRDS;
- Serum creatinine concentration less than 3.0 mg/dl;
- Serum potassium concentration less than or equal to 5.7 mEq/L;
- At least 2 of 3 screening urinary albumin-to-creatinine ratios greater than or equal to 300 mg/g;
- Willingness, after receiving a thorough explanation of the study, to participate.
- Severe hypertension will not affect eligibility for the study.
- EXCLUSION CRITERIA:
- In addition to the criteria outlined in the DRDS protocol, subjects with the following characteristics will be excluded:
- Pregnancy. Women of childbearing age and not surgically sterilized must have a negative pregnancy test prior to entry and prior to each renal clearance study.
- Hypersensitivity to ACE inhibitors.
- Conditions that are likely to interfere with informed consent or compliance with the protocol.
Exclusion
Key Trial Info
Start Date :
August 19 1994
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 16 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00353600
Start Date
August 19 1994
End Date
August 16 2011
Last Update
July 2 2017
Active Locations (1)
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1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014