← Back to Search

Other

AZD0780 for Kidney Failure

Phase 1

Recruiting

Led By Juan Carlos Rondon, Medicine

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 18 to 85 years of age, inclusive at the time of signing ICF

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to day 11

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD0780 on people with severe kidney problems and comparing it to people with normal kidney function. Participants will receive a single dose of the drug and will be

Who is the study for?

This trial is for adult men and women with severe kidney impairment or end-stage renal disease, who are not on dialysis or are on intermittent hemodialysis. Women must be of non-childbearing potential. Participants should have no other health conditions that could affect the study's results.

What is being tested?

The study tests AZD0780 in individuals with different levels of kidney function, including those with normal function, moderate impairment, severe impairment not on dialysis, and end-stage disease on hemodialysis. It's a single-dose study to see how the drug behaves in the body (pharmacokinetics) and its safety.

What are the potential side effects?

Specific side effects aren't listed but generally include how well AZD0780 is tolerated and any adverse reactions related to varying degrees of kidney function after taking a single oral dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUCinf

AUClast

Cmax

Secondary study objectives

Number of participants with abnormal laboratory test results

Number of participants with abnormal vital signs, abnormal ECGs, and abnormal physical examination findings

Number of participants with adverse events (AEs)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4 (optional): AZD0780Experimental Treatment1 Intervention

Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).

Group II: Group 3: AZD0780Experimental Treatment1 Intervention

Participants with normal renal function demographically matched by sex, age, and body mass index (BMI) to the impaired participants (eGFR of ≥ 90 mL/min)

Group III: Group 2: AZD0780Experimental Treatment1 Intervention

Participants with ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing.

Group IV: Group 1: AZD0780Experimental Treatment1 Intervention

Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD0780

2024

Completed Phase 2

~630