AZD6234 for Kidney Failure

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByFadi Saba, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AstraZeneca

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate the pharmacokinetics (PK), safety, and tolerability of single subcutaneous dose of AZD6234 with end stage renal disease, severe, and possibly moderate and mild renal impairment in comparison to a matched healthy control group.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but if you are renally-impaired, you need to be on a stable dose of cardio-renal treatment for at least 2 weeks before screening. You must avoid certain medications like phosphate binders and some others within 10 hours before and after the study intervention.

Eligibility Criteria

This trial is for individuals with varying degrees of kidney impairment, including those on dialysis or with end-stage renal disease. Healthy participants are also included for comparison.

Inclusion Criteria

I am between 18 and 85 years old.

My weight is at least 50 kg.

My kidney function is healthy, with an eGFR of 90 mL/min or more.

I have chronic kidney disease with stable kidney function for the last 3 months.

My kidney function is impaired according to a specific test.

I am using birth control methods other than the pill.

Exclusion Criteria

I have a disease affecting my nerves or muscles.

I have been diagnosed with major depression in the last 2 years.

I don't take any drugs without approval from the study team.

I have had significant stomach or intestine problems or surgery.

Participant Groups

The study tests how a single subcutaneous dose of AZD6234 is processed by the body (pharmacokinetics) and its safety and tolerability in people with different levels of kidney function compared to healthy individuals.

5Treatment groups

Experimental Treatment

Group I: Group 5 (optional)Experimental Treatment1 Intervention

Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Group II: Group 4 (optional)Experimental Treatment1 Intervention

Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Group III: Group 3Experimental Treatment1 Intervention

Healthy participants will receive a single subcutaneous dose of AZD6234 under fasted conditions

Group IV: Group 2Experimental Treatment1 Intervention

Subjects with severe renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Group V: Group 1Experimental Treatment1 Intervention

Subjects with end stage renal disease will receive a single subcutaneous dose of AZD6234 under fasted conditions