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

Primary Purpose

Chronic Kidney Disease, Proteinuria

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
aliskiren, eplerenon, telmisartan
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring aliskiren, eplerenon, telmisartan, direct renin inhibitor, ACE inhibitor, mineralocorticoid inhibitor, proteinuria, chronic kidney diseases, renin-angiotensin-aldosterone system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    C - A - B

    B - A - C

    A - B - C

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
    changes of UACR

    Secondary Outcome Measures

    Difference in transforming growth factor beta (TGF-beta) between treatment arms
    Changes of urinary excretion of transforming growth factor beta (TGF-beta)
    Difference in serum potassium and creatinine between treatment arms

    Full Information

    First Posted
    February 11, 2012
    Last Updated
    February 28, 2012
    Sponsor
    Medical University of Gdansk
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01541267
    Brief Title
    The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Gdansk

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Proteinuria
    Keywords
    aliskiren, eplerenon, telmisartan, direct renin inhibitor, ACE inhibitor, mineralocorticoid inhibitor, proteinuria, chronic kidney diseases, renin-angiotensin-aldosterone system

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    C - A - B
    Arm Type
    Active Comparator
    Arm Description
    (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
    Arm Title
    B - A - C
    Arm Type
    Active Comparator
    Arm Description
    (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
    Arm Title
    A - B - C
    Arm Type
    Active Comparator
    Arm Description
    (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
    Intervention Type
    Drug
    Intervention Name(s)
    aliskiren, eplerenon, telmisartan
    Intervention Description
    aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
    Primary Outcome Measure Information:
    Title
    Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
    Description
    changes of UACR
    Time Frame
    baseline and the end of 8 week treatments
    Secondary Outcome Measure Information:
    Title
    Difference in transforming growth factor beta (TGF-beta) between treatment arms
    Description
    Changes of urinary excretion of transforming growth factor beta (TGF-beta)
    Time Frame
    baseline and the end of 8 week treatments
    Title
    Difference in serum potassium and creatinine between treatment arms
    Time Frame
    baseline and the end of 8 week treatments

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bolesław Rutkowski, Professor
    Organizational Affiliation
    Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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