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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01541267

Enrollment

Registered

2012-02-29

Start date

2009-12-31

Completion date

2011-11-30

Last updated

2012-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Proteinuria

Keywords

aliskiren, eplerenon, telmisartan, direct renin inhibitor, ACE inhibitor, mineralocorticoid inhibitor, proteinuria, chronic kidney diseases, renin-angiotensin-aldosterone system

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

Interventions

DRUGaliskiren, eplerenon, telmisartan

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026