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NCT Number: NCT01541267

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aliskiren, eplerenon, telmisartan

Drug

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

Primary outcomes

  1. Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms

    Time frame: baseline and the end of 8 week treatments

    changes of UACR

Secondary outcomes

  1. Difference in transforming growth factor beta (TGF-beta) between treatment arms

    Time frame: baseline and the end of 8 week treatments

    Changes of urinary excretion of transforming growth factor beta (TGF-beta)

  2. Difference in serum potassium and creatinine between treatment arms

    Time frame: baseline and the end of 8 week treatments

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 29, 2012
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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