Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580288
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Effect of Finerenone in IgA Nephropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIGHT
Brief Summary:
The aim of this trial is to conduct a randomized multicenter placebo-controlled double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy
The primary endpoint event was the change in urinary albumincreatinine ratio between the two groups at 12 months of treatment
The primary endpoint event was the change in urinary albumincreatinine ratio between the two groups at 12 months of treatment
Detailed Description:
This is a randomized multicenter placebo-controlled double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy
Study population will include participants with renal biopsy confirmed IgA nephropathy eGFR 30 mLmin173 m2 and UACR 500mgg 3500mgg Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study
The study will be conducted at 4 sites 120 participants will be randomised to one of 2 arms in a 11 ratio
Finerenone 10mg20 mg
Placebo 10mg20 mg For each participant the total duration of participation will be approximately 12 months
Study population will include participants with renal biopsy confirmed IgA nephropathy eGFR 30 mLmin173 m2 and UACR 500mgg 3500mgg Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study
The study will be conducted at 4 sites 120 participants will be randomised to one of 2 arms in a 11 ratio
Finerenone 10mg20 mg
Placebo 10mg20 mg For each participant the total duration of participation will be approximately 12 months
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