100 Participants Needed

AZD6234 for Kidney Failure

Recruiting at 2 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca
Must be taking: Cardio-renal treatment
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.

Research Team

JM

Joel M Neutel, M.D.

Principal Investigator

Servico Integrado de Tecnicas Endovasculares

KA

Kwabena Ayesu, M.D.

Principal Investigator

Servico Integrado de Tecnicas Endovasculares

FS

Fadi Saba, M.D.

Principal Investigator

Servico Integrado de Tecnicas Endovasculares

TC

Thomas C Marbury, M.D.

Principal Investigator

Servico Integrado de Tecnicas Endovasculares

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

My weight is at least 50 kg.
BMI must be within the range of ≥ 18 to ≤ 40 kg/m2 as measured at screening
Healthy Matched Control Participants must be medically healthy with no clinically significant medical history or abnormalities in physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs as deemed by the investigator at screening and Day -1
See 7 more

Exclusion Criteria

Severe vitamin D deficiency < 12 ng/dL
I have a disease affecting my nerves or muscles.
My heart condition is considered significant by my doctor.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of AZD6234 under fasted conditions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • AZD6234
Trial Overview 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.
Participant Groups
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

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

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