AZD7760 for Chronic Kidney Failure
(PEAK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD7760 to assess its safety and behavior in the body. The first part involves healthy participants, while the second focuses on individuals with end-stage kidney disease undergoing hemodialysis through a central line. Those who have received hemodialysis for at least three months and use a central venous catheter may qualify for the second phase. The trial aims to compare different doses of the treatment to a placebo, which contains no active drug. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that no new medications should be added in the two weeks before starting the trial. Adjustments to existing medications are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD7760 is being tested for safety when administered as an infusion to individuals with kidney problems and healthy participants. This study is in its early stages, focusing primarily on how well participants tolerate the treatment. Currently, detailed information about side effects or adverse reactions is unavailable. However, the inclusion of both healthy individuals and those with severe kidney disease ensures that researchers closely monitor the treatment's safety and effects.
Early-stage studies like this aim to determine if a treatment is safe enough for further testing. Although specific safety data for AZD7760 is not yet available, its testing in humans suggests some evidence of potential safety. If participants tolerate the treatment well, it will progress to more advanced trials, where researchers will examine its safety and effectiveness in greater detail.12345Why do researchers think this study treatment might be promising for kidney failure?
Researchers are excited about AZD7760 for chronic kidney failure because it offers a novel approach compared to existing treatments like ACE inhibitors and angiotensin II receptor blockers. Unlike these standard therapies, which mainly work by controlling blood pressure and slowing kidney damage, AZD7760 might target specific pathways involved in kidney disease progression, potentially halting or even reversing damage. Additionally, the treatment’s delivery through a single intravenous dose could improve patient compliance and convenience, setting it apart from the daily oral regimens of current options.
What evidence suggests that AZD7760 might be an effective treatment for chronic kidney failure?
Research has shown that AZD7760 is a new treatment under study for its potential benefits in kidney health. While direct evidence on AZD7760's effectiveness for chronic kidney failure remains limited, it targets areas affecting kidney function, potentially slowing kidney damage. Early studies of similar treatments have shown promise in reducing signs of kidney stress. More research is needed to confirm these findings, but the scientific basis appears promising for improving kidney health.15678
Are You a Good Fit for This Trial?
This trial is for healthy adults and those with end-stage kidney disease on hemodialysis via a central venous catheter. Participants should meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dosing (Phase I)
Participants receive a single intravenous infusion of AZD7760 or placebo
Follow-up (Phase I)
Participants are monitored for safety and pharmacokinetics after the single dose
Dosing (Phase IIa)
Participants receive two intravenous infusions of AZD7760 or placebo, 3 months apart
Follow-up (Phase IIa)
Participants are monitored for safety and pharmacokinetics after the last dose
What Are the Treatments Tested in This Trial?
Interventions
- AZD7760
Trial Overview
The study tests the safety and how the body processes AZD7760, given intravenously. Phase I involves healthy participants; Phase IIa includes those with severe kidney disease on dialysis.
How Is the Trial Designed?
Participants will receive AZD7760 Dose E on Day 1 and Day 91.
Participants will receive AZD7760 Dose D and placebo on Day 1 on Day 91.
Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1.
Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1.
Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1.
Participants will receive a single dose of placebo on Day 1.
Participants will receive placebo on Day 1 and on Day 91.
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
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
NCT06749457 | A Study to Evaluate AZD7760 Safety and ...
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants ...
The long-term effects of dapagliflozin in chronic kidney ...
Attenuation of CKD progression was predicted to slow the time to kidney failure by 6.6 years [dapagliflozin: 25.2, 95% confidence interval (CI) ...
Top Kidney Failure Clinical Trials | Power
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula ( ...
4.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/astrazeneca-reports-positive-results-phase-iib-chronic-kidney-disease-trialAstraZeneca Reports Positive Results Phase IIb Chronic ...
The combination of zibotentan/dapagliflozin (AstraZeneca) produced a significant decrease in albuminuria in patients with chronic kidney disease (CKD) and ...
5.
astrazeneca.com
astrazeneca.com/content/astraz/media-centre/articles/2023/transforming-kidney-health-burden-ckd.htmlTransforming kidney health and the burden of CKD
In fact, survey data reveals that individuals living with CKD report 24% lower quality of life scores compared to the general population, with ...
AZD7760 for Chronic Kidney Failure (PEAK Trial)
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants ...
Pipeline
Our pipeline forms a robust portfolio of investigational therapies in varied stages of clinical development.
The effect of severe renal impairment on the pharmacokinetics ...
An acceptable safety profile was observed in a phase 2b study of balcinrenone plus dapagliflozin in patients with heart failure and reduced kidney function.
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