Renal Insufficiency, Chronic Clinical Trial
— CKDuOfficial title:
A Double Blind Clinical Trial to Examine the Renal Effects of an Angiotensin Converting Enzyme Inhibitor (Enalapril) in Adults With Chronic Kidney Disease of Uncertain Aetiology (CKDu)
Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | October 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Males and females between 18-70 years of age - CKDu Grade 1, 2, 3 - No contraindication for treatment with ACEI - Informed consent given Exclusion Criteria: - Grade 4 CKDu - Other chronic diseases - Evidence or suspicion of non renal secondary hypertension - Diabetes type 1 or 2 - Evidence or suspicion of renovascular disease, obstructive uropathy, or other renal disease - Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immune-suppressive drugs - Acute myocardial infarction or cerebrovascular accident in the previous 6 months - Severe uncontrolled hypertension (diastolic blood pressure =115 and/or systolic blood pressure =220 mm Hg) - Suspicion or evidence of connective tissue disease, cancer, higher serum aminotransferase concentrations - Chronic cough; drug or alcohol abuse; pregnancy and breast feeding - Unwillingness to sign informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sri Lanka | General (Teaching) Hospital, Anuradhapura | Anuradhapura | North Central |
Lead Sponsor | Collaborator |
---|---|
Ministry of Health, Sri Lanka | World Health Organization |
Sri Lanka,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proteinuria | Numerous clinical trials have established that angiotensin-converting enzyme inhibitors (ACEI) are beneficial in slowing progression of renal disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with ACEI did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease. | One year | No |
Primary | Estimated GFR | In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation. | One year | No |
Secondary | All cause mortality | One year | No | |
Secondary | Cardiovascular mortality | One year | No |
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