Status:
COMPLETED
Improving Outcomes in Patients With Kidney Disease Due to Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Kidney Disease
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
Kidney disease affects about one out of three people with diabetes mellitus, a common medical problem. Treatment of kidney disease with medications that lower blood pressure can slow the kidney diseas...
Detailed Description
The long-range objective of this project is to prevent progression of diabetic nephropathy, the leading cause of end-stage renal disease (ESRD). In most patients diabetic nephropathy progresses inexor...
Eligibility Criteria
Inclusion
- Adult male and female subjects aged 20-65 of all ethnic backgrounds.
- Type I diabetes mellitus defined as sudden onset of insulin requiring diabetes prior to age 20 and at least 5 years duration
- Type 2 diabetes mellitus defined as onset \> 20 years of age and treatment with oral hypoglycemic agent and/or insulin and increased C-peptide level.
- Seated SBP \> 130 mmHg documented at one screening visit or treated SBP \< 130 mmHg with a documented history of SBP \> 130 mmHg on more than one previous occasion
- Proteinuria defined as a 24-hour urine albumin/creatinine ratio \> 300 mg/g while on an ACE inhibitor with or without non-ARB, non-aldosterone antagonist treatment
- Ongoing treatment (\> 3 months) with an ACE inhibitor or ARB with or without additional antihypertensive therapy (e.g. CCB, a-blocker, b-blocker, clonidine).
Exclusion
- BMI \> 45 kg/m2
- Baseline serum creatinine \> 3.0 mg/dl in females and \> 4.0 mg/dl in males or creatinine clearance \<20 ml/min estimated by Cockcroft-Gault equation (based on age, fasting serum creatinine concentration and ideal body weight in kilograms).
- Secondary cause of kidney disease other than diabetic nephropathy
- Serum potassium concentration \>5.5 mEq/L on ACE inhibitor therapy 7-10 days prior to randomization
- Poorly controlled diabetes, i.e. HgbA1C \> 11 mg/dl 7-10 days prior to randomization
- History of allergy to iothalamate or history of renal failure due to contrast nephropathy
- Stroke or myocardial infarction within the preceding 12 months prior to randomization
- Coronary revascularization procedure within past 6 months
- Clinically apparent congestive heart failure defined as clinical signs of heart failure or an ejection fraction of \< 40% (and/or depressed LV systolic function by echocardiogram).
- Terminal disease including cancer and AIDS
- Documented increase in serum creatinine \> 50% of baseline within 3 months prior to the run-in period
- Renal disease known or in the opinion of the investigator caused by a condition other than diabetes
- Known adverse reaction to study medications including ACE inhibitors, ARB and spironolactone
- History of chronic or intermittent gross hematuria
- Spontaneous 24-hour urine sodium excretion rate exceeding 350 mEq/day
- AST or ALT greater than 2.5 the upper limit of normal for the laboratory
- Pregnancy
- History of autoimmune disease, connective tissue disease or multiple drug allergies
- Anticipated need for renal replacement therapy within 12 months Inclusion criteria for normal subjects
- Adult male and female subjects aged 20-65 of all ethnic backgrounds Exclusion criteria for normal subjects
- Chronic medical conditions, including but not limited to diabetes mellitus, hypertension, chronic kidney disease, and hyperlipidemia.
- Use of medications for antihypertensive
- Inability to follow study protocol for any reason
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00381134
Start Date
July 1 2003
End Date
December 1 2006
Last Update
March 2 2010
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75230