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

Medical University of Gdansk

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Proteinuria

Treatments: Drug: aliskiren, eplerenon, telmisartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01541267

ST-4/Aliskiren/2011

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

C - A - B

Active Comparator group

Description:

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Treatment:

Drug: aliskiren, eplerenon, telmisartan

B - A - C

Active Comparator group

Description:

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Treatment:

Drug: aliskiren, eplerenon, telmisartan

A - B - C

Active Comparator group

Description:

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Treatment:

Drug: aliskiren, eplerenon, telmisartan