AZD5004 for Kidney Failure

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

21 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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 and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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