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

Sponsor

Medical University of Gdansk (Other)

Overall Status

Completed

CT.gov ID

NCT01541267

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Proteinuria	Drug: aliskiren, eplerenon, telmisartan	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria in Chronic Non-diabetic Kidney Disease: a Double-blind Cross-over Randomised Controlled Study

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: C - A - B (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg	Drug: aliskiren, eplerenon, telmisartan aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
Active Comparator: B - A - C (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg	Drug: aliskiren, eplerenon, telmisartan aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
Active Comparator: A - B - C (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg	Drug: aliskiren, eplerenon, telmisartan aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Arm

Intervention/Treatment

Active Comparator: C - A - B

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

Drug: aliskiren, eplerenon, telmisartan

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Active Comparator: B - A - C

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

Drug: aliskiren, eplerenon, telmisartan

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Active Comparator: A - B - C

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

Drug: aliskiren, eplerenon, telmisartan

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Outcome Measures

Primary Outcome Measures

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

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)
Difference in serum potassium and creatinine between treatment arms [baseline and the end of 8 week treatments]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Gdansk

Investigators

Principal Investigator: Bolesław Rutkowski, Professor, Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland