AZD6234 for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD6234 (an experimental drug) for individuals with kidney failure. The main goal is to determine how the drug behaves in the body and assess its safety and tolerability. Participants will be grouped based on kidney function, ranging from healthy individuals to those with varying levels of kidney impairment, including end-stage kidney failure. Individuals with stable chronic kidney disease who manage their condition, particularly those with controlled diabetes, might be suitable for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but if you are renally-impaired, you need to be on a stable dose of cardio-renal treatment for at least 2 weeks before screening. You must avoid certain medications like phosphate binders and some others within 10 hours before and after the study intervention.
Is there any evidence suggesting that AZD6234 is likely to be safe for humans?
Research has shown that AZD6234 is being tested for safety in individuals with kidney problems, including those with varying levels of kidney function, even severe kidney disease.
As this is an early-stage trial, the primary goal is to observe how the body processes the drug and to identify any side effects. Although detailed safety information from earlier studies is not available, reaching this testing phase indicates that AZD6234 has passed initial lab tests and is considered safe enough for human trials. Participants will receive a single dose of the drug, allowing researchers to monitor for any immediate reactions.
Safety information is still being collected, and observations from the trial will help determine how well AZD6234 is tolerated in humans.12345Why do researchers think this study treatment might be promising for kidney failure?
Unlike the standard treatments for kidney failure, which often involve dialysis or kidney transplantation, AZD6234 is an innovative approach that is administered as a single subcutaneous dose. Researchers are excited about AZD6234 because it offers a potentially less invasive and more convenient alternative for patients. The unique delivery method of a subcutaneous injection under fasted conditions may improve patient adherence and comfort compared to traditional options. Additionally, AZD6234 might target kidney function differently, which could lead to better outcomes for patients with varying degrees of renal impairment.
What evidence suggests that AZD6234 might be an effective treatment for kidney failure?
Researchers are investigating AZD6234 to determine its potential benefits for individuals with kidney problems, particularly those with severe or end-stage kidney disease. In this trial, participants will receive a single subcutaneous dose of AZD6234 under fasted conditions, with groups including healthy participants and those with varying degrees of renal impairment. Studies have primarily focused on the drug's mechanism of action. Early results suggest it might improve kidney function by targeting specific areas involved in kidney damage. While detailed information on its efficacy in humans is still being gathered, its mechanism appears promising as it aims to address the root causes of kidney failure. As research progresses, clearer evidence about its effectiveness is expected.13467
Who Is on the Research Team?
Fadi Saba, M.D.
Principal Investigator
Servico Integrado de Tecnicas Endovasculares
Thomas C Marbury, M.D.
Principal Investigator
Servico Integrado de Tecnicas Endovasculares
Kwabena Ayesu, M.D.
Principal Investigator
Servico Integrado de Tecnicas Endovasculares
Joel M Neutel, M.D.
Principal Investigator
Servico Integrado de Tecnicas Endovasculares
Are You a Good Fit for This Trial?
This trial is for individuals with varying degrees of kidney impairment, including those on dialysis or with end-stage renal disease. Healthy participants are also included for comparison.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of AZD6234 under fasted conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6234
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