Balcinrenone + Dapagliflozin for Renal Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
Are You a Good Fit for This Trial?
This trial is for adults with kidney failure who have been on stable, regular hemodialysis for at least 3 months. Participants must be generally healthy aside from their kidney condition, able to give consent, and meet certain weight and medication stability requirements. Women of childbearing age must use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive Treatment A or B, with pharmacokinetic assessments conducted over 4 days
Wash-out
A wash-out period of at least 7 days between treatment periods
Treatment Period 2
Participants receive the alternate treatment (A or B), with pharmacokinetic assessments conducted over 4 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Balcinrenone/dapagliflozin
Trial Overview
The study tests how a single dose of balcinrenone/dapagliflozin behaves in the body and its safety in people with kidney failure on hemodialysis. Researchers want to see if dialysis affects these drugs' levels or side effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completionof a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1.5 hours before the start of a 4-hour hemodialysis session)
Participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1,5 hours before the start of a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completion of a 4-hour hemodialysis session)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Fortrea
Industry Sponsor
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