Status:
COMPLETED
Renoprotection in Early 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
Phase:
PHASE3
Brief 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...
Detailed Description
This investigation is a randomized, double-blinded, placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine ratio \< 30 mg/g) or m...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Volunteers from the Gila River Indian Community who meet the eligibility criteria will be invited to participate.
- To be eligible for participation in the study, subjects must meet the following criteria:
- Aged 18-65.
- Diagnosis of type 2 diabetes greater than or equal to 5 years.
- Serum creatinine concentration less than to 1.4 mg/dl.
- Serum potassium concentration less than or equal to 5.5 milliequivalents (mEq)/L.
- At least 2 of 3 weekly screening urinary albumin-to-creatinine ratios less than 300 mg/g. All screening tests are to be within 3 months of enrollment.
- Willingness, after receiving a thorough explanation of the study, to participate.
- EXCLUSION CRITERIA:
- Subjects will be excluded for the following reasons:
- Clinically significant disorders of the liver, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, pulmonary diseases, renal-urinary disorders, gastrointestinal disorders, or hematocrit levels less than or equal to 30 percent in women or less than or equal to 35 percent in men.
- Renovascular or malignant hypertension; uncontrolled hypertension despite treatment with three antihypertensive drugs; or hypertension that is being treated with antihypertensive medicines and the primary care physician or the patient refuses to adopt the blood pressure treatment regimen outlined in the study protocol.
- Hematuria of unknown etiology.
- Chronic debilitating disorders with or without treatment that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate efficacy of treatment.
- Currently receiving a drug regimen that includes: steroids, immunosuppressants, or investigational new drugs.
- Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and every three months during the study.
- Evidence of inability to empty the bladder.
- Hypersensitivity to angiotensin-converting enzyme inhibitors (ACEi), ARBs, or iodine.
- Bleeding disorders, since kidney biopsies could not be performed safely in these individuals.
- Massive obesity with body mass index greater than or equal to 45 kg/m(2).
- Non-diabetic renal disease.
- Conditions that are likely to interfere with informed consent or compliance with the protocol.
Exclusion
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00340678
Start Date
August 1 1995
End Date
March 1 2014
Last Update
March 25 2021
Active Locations (1)
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1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014