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Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

Primary Purpose

Kidney Disease, Diabetic Nephropathy, Glomerulonephritis

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Spironolactone
Irbesartan
Sponsored by
Melbourne Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Disease focused on measuring spironolactone, proteinuria, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, renin angiotensin aldosterone system, aldosterone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Proteinuria more than 1.5 g/day On ACEI for more than 6 months Serum creatinine less than 200 micromol/L with less than 20% variability in the preceeding 3 months Creatinine clearance more than 30 ml/min, with less than 20% variability in the preceeding 3 months Exclusion Criteria: Serum potassium level more than 5 mmol/L Treatment with corticosteroids, NSAID or immunosuppressant medication Acute myocardial infarction or cerebrovascular accident in the previous 6 months Severe uncontrolled hypertension (diastolic > 115 mmHg or systolic BP [blood pressure] > 220 mmHg) Evidence or suspicion of renovascular disease, obstructive uropathy, collagen disease, cancer, drug or alcohol abuse, pregnancy, or breast feeding and ineffective contraception

Sites / Locations

  • Department of Nephrology, The Royal Melbourne Hospital

Outcomes

Primary Outcome Measures

percent reduction in 24 hour urine protein excretion

Secondary Outcome Measures

Full Information

First Posted
March 25, 2005
Last Updated
June 23, 2005
Sponsor
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT00106561
Brief Title
Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
Official Title
A Double-Blind, Placebo-Controlled Study on the Effect of Spironolactone, in Patients With Persistent Proteinuria on Long-Term Angiotensin Converting Enzyme Inhibitor Therapy, With or With Out an Angiotensin II Receptor Blocker
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Melbourne Health

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine which combination of the tablets ramipril, irbesartan or spironolactone is best to lower protein leakage from the kidney.
Detailed Description
Protein leak from the kidney into the urine is an indicator of kidney damage. The higher the leak, the worse the damage and the more likely the patient will lose their kidney function long term. Interventions that lower protein leak make the kidneys last longer. There are 2 groups of medications, both blood pressure tablets, the ACEI (angiotensin converting enzyme inhibitors) and ATRB (angiotensin receptor blockers) which have shown to reduce the amount of protein leaking from the kidney and as a result lengthen the life of the kidney. There has also been evidence that using these 2 tablets in combination is better than using either one alone. In spite of these tablets, there still remain some patients that continue to leak protein in the urine. Recently there has been evidence that the tablet spironolactone, which is a fluid tablet, also reduces protein leakage from the kidney. In this study we look at various combinations of these tablets to see which works best to lower protein leakage from the kidney. Patients are divided into 4 groups. Each group will receive the tablet ramipril (an ACEI). In group 1, patients will be on ramipril and 2 blank tablets, group 2 will be on ramipril, irbesartan (an ATRB) and a blank tablet, group 3 will be on ramipril, spironolactone and a blank tablet and group 4 will be on ramipril, irbesartan and spironolactone. Protein leakage is measured at the beginning and after 3 months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Diabetic Nephropathy, Glomerulonephritis, Proteinuria
Keywords
spironolactone, proteinuria, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, renin angiotensin aldosterone system, aldosterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Primary Outcome Measure Information:
Title
percent reduction in 24 hour urine protein excretion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proteinuria more than 1.5 g/day On ACEI for more than 6 months Serum creatinine less than 200 micromol/L with less than 20% variability in the preceeding 3 months Creatinine clearance more than 30 ml/min, with less than 20% variability in the preceeding 3 months Exclusion Criteria: Serum potassium level more than 5 mmol/L Treatment with corticosteroids, NSAID or immunosuppressant medication Acute myocardial infarction or cerebrovascular accident in the previous 6 months Severe uncontrolled hypertension (diastolic > 115 mmHg or systolic BP [blood pressure] > 220 mmHg) Evidence or suspicion of renovascular disease, obstructive uropathy, collagen disease, cancer, drug or alcohol abuse, pregnancy, or breast feeding and ineffective contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gavin G Becker, MBBS MD
Organizational Affiliation
Director Department of Nephrology, The Royal Melbourne Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Nephrology, The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11565535
Citation
Chrysostomou A, Becker G. Spironolactone in addition to ACE inhibition to reduce proteinuria in patients with chronic renal disease. N Engl J Med. 2001 Sep 20;345(12):925-6. doi: 10.1056/NEJM200109203451215. No abstract available.
Results Reference
background
PubMed Identifier
33107592
Citation
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Results Reference
derived

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Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

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