Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ib Double-blind Placebo-controlled Randomised Trial Investigating the Effect of AZD3427 on Renal Perfusion in HFrEF Patients With Renal Impairment Using Positron Emission Tomography PET
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Re-PERFUSE
Brief Summary:
The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR 30 to 90 mLmin173m2
Detailed Description:
This is a Phase Ib randomised double-blind placebo-controlled single-dose single-centre study to evaluate the renal haemodynamic effects of AZD3427 in participants with heart failure and reduced eGFR This study will evaluate changes in the volumetric fraction of perfused renal cortex after a single dose of AZD3427 or AZD3427 placebo These changes will be assessed using 15OH2O PET imaging of the kidneys Additional endpoints include changes in total renal perfusion plasmaserum biomarkers of renal function and safety and tolerability Infusion with 2 to 4 µgkgmin dopaminesaline placebo will be used as a positive control
Study details include
The study duration will be up to 83 days
The treatment duration will be 1 day
The visit frequency will be on Day 1 Day 8 3 days and Day 56 3 days
Study details include
The study duration will be up to 83 days
The treatment duration will be 1 day
The visit frequency will be on Day 1 Day 8 3 days and Day 56 3 days
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