AZD0780 for Kidney Failure
Trial Summary
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop some medications. Participants with normal renal function must stop using any prescription or non-prescription drugs 7 days before the study, unless approved by the investigator. Participants with renal impairment must avoid certain medications like potassium binders and phosphate binders 10 hours before and after the study dose, and other specific drugs as outlined in the protocol.
What data supports the idea that AZD0780 for Kidney Failure is an effective treatment?
What safety data exists for AZD0780 in treating kidney failure?
Is the drug AZD0780 a promising treatment for kidney failure?
What is the purpose of this trial?
This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-childbearing potential) with severe renal impairment not on dialysis, end-stage renal disease (ESRD) on intermittent haemodialysis (HD), or moderate renal impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal renal function. Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention. Eligible participants will be admitted to the study site on Day -1. On Day 1, an "A" single oral dose of AZD0780 will be administered, and participants will be confined to the study site until after assessments are completed on Day 11.
Research Team
Kwabena Ayesu, MD
Principal Investigator
Omega Research Orlando
Thomas C Marbury
Principal Investigator
Orlando Clinical Research Center
Trisha Shamp, Medicine
Principal Investigator
Nucleus Network
Juan Carlos Rondon, Medicine
Principal Investigator
Clinical Pharmacology of Miami, Inc.
Joel M Neutel
Principal Investigator
Orange County Research Center
Eligibility Criteria
This trial is for adult men and women with severe kidney impairment or end-stage renal disease, who are not on dialysis or are on intermittent hemodialysis. Women must be of non-childbearing potential. Participants should have no other health conditions that could affect the study's results.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of AZD0780 and are confined to the study site for assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AZD0780
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