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Clinical Trial Details

Trial ID: L0548
Source ID: NCT01624064
Associated Drug: Enalapril
Title: Renal Effects of an Angiotensin Converting Enzyme Inhibitor in Adults With Chronic Kidney Disease of Uncertain Aetiology
Acronym: CKDu
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Renal Insufficiency, Chronic
Interventions: DRUG: Enalapril|DRUG: Calcium Supplement
Outcome Measures: 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|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 | Secondary: All cause mortality, One year|Cardiovascular mortality, One year
Sponsor/Collaborators: Sponsor: Ministry of Health, Sri Lanka | Collaborators: World Health Organization
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2013-10
Results First Posted:
Last Update Posted: 2012-06-20
Locations: General (Teaching) Hospital, Anuradhapura, Anuradhapura, North Central, Sri Lanka
URL: https://clinicaltrials.gov/show/NCT01624064