AZD5004 for Kidney Failure

No longer recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Diabetes, Hypertension, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD5004 (also known as ECC5004) for individuals with kidney problems. The main goal is to assess the safety and tolerability of the treatment in those with severe kidney issues compared to those with normal kidney function. Participants will receive a single dose of the treatment, and the trial will include different groups: one with severe kidney impairment, one with normal kidney function, and possibly one with moderate kidney impairment. Suitable candidates are those who have experienced severe kidney issues for at least six months and do not have uncontrolled diabetes or high blood pressure. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires that there be no changes in your baseline medication within 2 weeks before starting the study.

Is there any evidence suggesting that AZD5004 is likely to be safe for humans?

Research has shown that AZD5004 underwent safety testing in earlier studies. Participants tolerated the treatment well, and researchers found no major safety issues. This trial is in its early stages, focusing primarily on the drug's safety and how the body processes it. Current data suggest that AZD5004 is safe for humans when used in controlled amounts. However, as this is an early-stage trial, ongoing research will continue to closely monitor its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney failure?

Researchers are excited about AZD5004 for kidney failure because it offers a novel approach to treating renal impairment. Unlike traditional treatments that primarily focus on managing symptoms and slowing disease progression, AZD5004 is designed to address the underlying causes of kidney damage. This drug is unique due to its innovative mechanism of action that specifically targets renal function, potentially leading to improved outcomes for patients with varying levels of kidney impairment. Its ability to be administered as a single oral dose under fasted conditions also sets it apart, offering a convenient option for patients.

What evidence suggests that AZD5004 might be an effective treatment for kidney failure?

Research has shown that AZD5004 is under study for its potential to treat kidney failure. In this trial, participants with varying levels of renal function—severe, moderate, and normal—will receive a single oral dose of AZD5004 under fasted conditions. Early studies tested AZD5004 in individuals with diabetes and obesity, and results suggested it might improve kidney health. The treatment affects certain bodily processes related to kidney function. Initial findings in healthy volunteers and those with diabetes indicated it may help manage conditions linked to kidney problems. Although detailed human data specifically on kidney failure remains limited, these early results offer a promising start for its use in kidney-related conditions. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women with severe or moderate kidney failure, compared to those with normal kidney function. It's designed to understand how a new drug, AZD5004, behaves in the body and its safety.

Inclusion Criteria

I have kidney problems with specific eGFR levels for at least 6 months.

I weigh more than 50kg and my BMI is between 18-40.

My kidneys are healthy with an eGFR rate of 90 or above.

Exclusion Criteria

I do not have unstable health conditions or severe psychological issues.

My diabetes is not well-managed, with an A1C over 10% or recent severe symptoms.

I am not willing to use birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of AZD5004 under fasted conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability from Day 1 to Day 10

10 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AZD5004

Trial Overview The study tests AZD5004 in participants with different levels of kidney health. It's an open-label study where everyone knows what treatment they're getting, and it looks at how the drug moves through the body (pharmacokinetics).

How Is the Trial Designed?

Group I: Group 3 (Optional) Experimental Treatment 1 Intervention

Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

Group II: Group 2 Experimental Treatment 1 Intervention

Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.

Group III: Group 1 Experimental Treatment 1 Intervention

Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

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

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7260C00006

A Phase I Study to Investigate the Effect of Renal ... This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11701199/

Non‐clinical and first‐in‐human characterization of ... These data support continued development of ECC5004 as a potential therapy for T2DM and overweight or obesity. Clinical trial registration: NCT05654831.

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.16047

Non‐clinical and first‐in‐human characterization of ECC5004 ... This study evaluated single doses of ECC5004 (1–300 mg) in healthy volunteers, and multiple daily doses (5, 10, 30 and 50 mg) in patients with T2DM for 28 days.

4. withpower.com withpower.com/trial/phase-1-renal-insufficiency-11-2024-bc637

AZD5004 for Kidney Failure · Info for Participants This trial is for men and women with severe or moderate kidney failure, compared to those with normal kidney function. It's designed to understand how a new ...

5. clinicaltrials.eu clinicaltrials.eu/inn/azd5004/

AZD5004: A Promising New Drug for Diabetes and Obesity ... This clinical trial is focused on studying the effects of a new treatment called AZD5004 for individuals living with obesity or who are overweight and have at ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16047

Non‐clinical and first‐in‐human characterization of ECC5004 ... To evaluate safety, ECC5004 was orally administered to NHPs for 9 months and a phase I, double-blind, placebo-controlled FIH study was ...

7. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2023/agreement-with-eccogene-for-clinical-stage-glp-1ra.html

AstraZeneca licenses novel agent for the treatment of ... ECC5004 has been demonstrated in preclinical studies to possess desirable efficacy and safety profiles. Cardiovascular, Renal and Metabolism ( ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39962632/

The effect of severe renal impairment on ... The aim of this phase 1 trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone (previously AZD9977) in participants with severe ...