231 Participants Needed

AZD7760 for Chronic Kidney Failure

(PEAK Trial)

Recruiting at 35 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center

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.12345

Why 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

I am healthy with no significant diseases or medications.
My weight is between 45 and 110 kg, and my BMI is between 18.0 and 30.0.
I have end-stage kidney disease and am on hemodialysis.

Exclusion Criteria

Phase I: Known hypersensitivity to any component of the study intervention
I have no major health issues that could affect my safety in the study.
Phase IIa: Known hypersensitivity to any component of the study intervention
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dosing (Phase I)

Participants receive a single intravenous infusion of AZD7760 or placebo

3 days
1 visit (in-person)

Follow-up (Phase I)

Participants are monitored for safety and pharmacokinetics after the single dose

12 months

Dosing (Phase IIa)

Participants receive two intravenous infusions of AZD7760 or placebo, 3 months apart

6 months
2 visits (in-person)

Follow-up (Phase IIa)

Participants are monitored for safety and pharmacokinetics after the last dose

12 months

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?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase IIa: AZD7760 Dose EExperimental Treatment1 Intervention
Group II: Phase IIa: AZD7760 Dose D and PlaceboExperimental Treatment2 Interventions
Group III: Phase I: AZD7760 Dose CExperimental Treatment1 Intervention
Group IV: Phase I: AZD7760 Dose BExperimental Treatment1 Intervention
Group V: Phase I: AZD7760 Dose AExperimental Treatment1 Intervention
Group VI: Phase I: PlaceboPlacebo Group1 Intervention
Group VII: Phase IIa: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

Trials
322
Recruited
137,000+
Peyton Howell profile image

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 profile image

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 ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38730538/
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 | PowerThis is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula ( ...
AstraZeneca 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 ...
Transforming kidney health and the burden of CKDIn 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 ...
PipelineOur 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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