Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106561
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2005-03-25
Brief Title:
Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None