Trials / Terminated
TerminatedNCT06611423
AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment
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
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
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 mL/min/1.73m2).
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 \[15O\]H2O PET imaging of the kidneys. Additional endpoints include changes in total renal perfusion, plasma/serum biomarkers of renal function, and safety and tolerability. Infusion with 2 to 4 µg/kg/min dopamine/saline 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AZD3427 | AZD3427 SC injection to be prepared using AZD3427 diluent |
| OTHER | AZD3427 Placebo | AZD3427 Placebo |
| DRUG | Dopamine | Dopamine Hydrochloride 50mg/5mL |
| OTHER | Radiolabelled ligand | Injection of radioligand for PET examinations |
| OTHER | Saline | Saline solution |
Timeline
- Start date
- 2024-10-15
- Primary completion
- 2025-08-21
- Completion
- 2025-08-21
- First posted
- 2024-09-25
- Last updated
- 2025-09-24
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06611423. Inclusion in this directory is not an endorsement.