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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leszek Tylicki, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01541267
First received: February 11, 2012
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Proteinuria
Drug: aliskiren, eplerenon, telmisartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms [ Time Frame: baseline and the end of 8 week treatments ] [ Designated as safety issue: No ]
    changes of UACR


Secondary Outcome Measures:
  • Difference in transforming growth factor beta (TGF-beta) between treatment arms [ Time Frame: baseline and the end of 8 week treatments ] [ Designated as safety issue: No ]
    Changes of urinary excretion of transforming growth factor beta (TGF-beta)

  • Difference in serum potassium and creatinine between treatment arms [ Time Frame: baseline and the end of 8 week treatments ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541267

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
  More Information

No publications provided

Responsible Party: Leszek Tylicki, MD PhD, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01541267     History of Changes
Other Study ID Numbers: ST-4/Aliskiren/2011
Study First Received: February 11, 2012
Last Updated: February 28, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Gdansk:
aliskiren
eplerenon
telmisartan
direct renin inhibitor
ACE inhibitor
mineralocorticoid inhibitor
proteinuria
chronic kidney diseases
renin-angiotensin-aldosterone system

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Renal Insufficiency, Chronic
Renal Insufficiency
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Eplerenone
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014