Macroalbuminuric Diabetic Nephropathy
Conditions
Keywords
diabetic nephropathy, proteinuria, CKD progression, dialysis
Brief 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.
Detailed 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.
Interventions
DRUGenalapril
DRUGlosartan
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetic nephropathy characterised by a daily proteinuria superior to 500 mg * type II diabetes
Exclusion criteria
* type 1 diabetes * serum creatinine \> 2.5 mg/dL or creatinine clearance lower than 30 ml/min * serum potassium \> 5.5 mEq/L * intolerance or allergy to ACE inhibitors or BRA * pregnancy * hepatitis C or B * HIV * current chemotherapy treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effect of treatment on proteinuria after 8 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up | — |
| incidence of hyperkalemia | — |
Countries
Brazil
Outcome results
None listed