The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Proteinuria
• Interventions: Drug: aliskiren, eplerenon, telmisartan

• Registration Number: NCT01541267
• Lead Sponsor: Medical University of Gdansk

Brief Summary

The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.

Detailed Description

Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.

The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-05
• Study Completion: 2011-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-11
• Study First Submitted QC: 2012-02-28
• Last Update Submitted: 2012-02-28
• Study First Posted: 2012-02-29
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age 18-65 years
• chronic non-diabetic proteinuric nephropathy
• chronic kidney disease stage 1-3
• stable proteinuria above 500 mg/24 hours
• blood pressure above 125/75 mmHg and below 150/95 mmHg
• no steroids or other immunosuppressive treatment for a minimum of six months before the study

Exclusion Criteria

• unstable coronary heart disease
• decompensated congestive heart failure in the previous 6 months
• episode of malignant hypertension or stroke in the history
• diabetes
• creatinine clearance below 30 ml/min
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C - A - B	aliskiren, eplerenon, telmisartan	(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
B - A - C	aliskiren, eplerenon, telmisartan	(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
A - B - C	aliskiren, eplerenon, telmisartan	(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Primary Outcome Measures

Name	Time	Method
Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms	baseline and the end of 8 week treatments	changes of UACR

Secondary Outcome Measures

Name	Time	Method
Difference in serum potassium and creatinine between treatment arms	baseline and the end of 8 week treatments
Difference in transforming growth factor beta (TGF-beta) between treatment arms	baseline and the end of 8 week treatments	Changes of urinary excretion of transforming growth factor beta (TGF-beta)