Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00106561




Registration number
NCT00106561
Ethics application status
Date submitted
25/03/2005
Date registered
28/03/2005
Date last updated
24/06/2005

Titles & IDs
Public title
Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
Scientific 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
Secondary ID [1] 0 0
RMH2001-142
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 0 0
Diabetic Nephropathy 0 0
Glomerulonephritis 0 0
Proteinuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
percent reduction in 24 hour urine protein excretion
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Nephrology, The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00106561
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gavin G Becker, MBBS MD
Address 0 0
Director Department of Nephrology, The Royal Melbourne Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00106561