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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541267
• Other study ID #: ST-4/Aliskiren/2011
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2012
• Last updated: February 28, 2012
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms	changes of UACR	baseline and the end of 8 week treatments	No
Secondary	Difference in transforming growth factor beta (TGF-beta) between treatment arms	Changes of urinary excretion of transforming growth factor beta (TGF-beta)	baseline and the end of 8 week treatments	No
Secondary	Difference in serum potassium and creatinine between treatment arms		baseline and the end of 8 week treatments	Yes