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Clinical Trial Summary

Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to decrease the rate of progression of this disease and reduce the number of patients needing dialysis or renal transplantation are urgently needed. In this study we wish to compare the effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with diabetic chronic nephropathy.


Clinical Trial Description

Diabetic kidney disease is the current leading cause of chronic kidney disease (CKD) in the world. Despite all efforts to control this disease, rates of CKD progression are still high and a significant number of patients will ultimately need renal replacement therapy. Pharmacological blockade of renin-angiotensin system is one of the key elements of CKD secondary prevention, and ACE inhibitors or angiotensin II receptor 1 blocker (ARB)can be used for this purpose. However, it is still not clear if dual blockade (ACEi and ARBs simultaneously)is superior to monotherapy with ACE inhibitors or ARBs. A recent trial has suggested that dual blockade is superior to monotherapy in non-diabetic chronic kidney disease. The purpose of this trial is to evaluate the effect of combination therapy compared to ACE inhibitors alone in type 2 diabetic patients with macroalbuminuric diabetic nephropathy. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00419835
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Phase 4
Start date May 2005
Completion date September 2007

See also
  Status Clinical Trial Phase
Terminated NCT00961207 - Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients Phase 4