Renal ImpairmentPhase 1NCT06845813

Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

A Phase 1 study testing AZD6234 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: AZD6234
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 24 Feb 2025to 30 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant must be 18 to 85 years of age, inclusive, at the time of signing the informed consent.
Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured at screening.
Healthy Matched Control Participants:
Participant 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.
Have an eGFR of ≥ 90 mL/min determined at screening.
Renally-impaired Participants:

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Diagnosis of chronic kidney disease, stable renal function in the 3 months prior to dosing,
Participants with renal impairment based on BSA-adjusted CKD-EPI equation at screening.
All renally-impaired participants should be on a stable dose of cardio-renal relevant treatment for at least 2 weeks prior to screening.
If participants with renal impairment have diabetes mellitus, it must be controlled
Female(s) of childbearing potential: must use adequate contraception. Oral contraceptives are not permitted as there is a potential effect of the IMP on the absorption of oral drugs.
Male Participants: Condom use is required for the duration of the study and until at least 28 days after the last dose of IMP. Additional contraception must be used for the sexual partners of male study participants throughout the clinical trial and for 28 days following the last dose of IMP.

Who cannot join

History or presence of: significant GI disease or previous upper GI surgery
Clinically significant cardiovascular disease, as judged by the investigator, d. Neuromuscular or neurogenic disease e. Severe vitamin D deficiency < 12 ng/dL.
History or presence of any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
History of psychosis, bipolar disorder
History of major depressive disorder within the past 2 years
History of suicide attempt or history of suicidal ideation within the past year.

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Healthy Matched Control Participants:
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
Use of any prescription or non-prescription drugs, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Renally-impaired Participants:
Presence of unstable medical condition or any evidence of additional severe or uncontrolled systemic disease or laboratory finding which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.
Renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed.
Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine within 7 days of Day -1.
Unable to refrain from phosphate binders, cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Research Site
Lake Forest, California, 92630
Research Site
Orlando, Florida, 32808
Research Site
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

Read the detailed description

This Phase I multicentre, single-dose, non-randomised, open-label, parallel-group study aims to examine the pharmacokinetics, safety, and tolerability of AZD6234 in both male and female participants. Participants include those with end-stage renal disease (ESRD) on intermittent haemodialysis (HD), severe renal impairment not on dialysis, and optional groups for moderate and mild renal impairment. These are compared to participants with normal renal function. All participants are grouped based on body surface area-adjusted estimated glomerular filtration rate (eGFR), and those with normal renal function are matched at a group level by sex, age, and body mass index (BMI) to the participants with impaired renal function.

Conditions: Renal Impairment
Being tested: AZD6234
Keywords: Renal Impairment, Healthy Participants, AZD6234, Pharmacokinetics, Safety
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD6234Drug
Also called Dose 1
Dose 1

Study groups in NCT06845813
Study group	Role	What they receive
Group 1	Experimental	Subjects with end stage renal disease will receive a single subcutaneous dose of AZD6234 under fasted conditions Receives: Drug: AZD6234
Group 2	Experimental	Subjects with severe renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions Receives: Drug: AZD6234
Group 3	Experimental	Healthy participants will receive a single subcutaneous dose of AZD6234 under fasted conditions Receives: Drug: AZD6234
Group 4 (optional)	Experimental	Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions Receives: Drug: AZD6234
Group 5 (optional)	Experimental	Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions Receives: Drug: AZD6234

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Measured: Day 1 to Day 36
AUCinf
Area under plasma concentration-time curve from zero to infinity
Measured: Day 1 to Day 36
Cmax
Maximum observed plasma concentration
Measured: Day 1 to Day 36

Secondary outcomes (11)

Tmax
Time to reach maximum observed plasma concentration
Measured: Day 1 to Day 36
PK parameter (t1/2λz)
Terminal elimination half-life
Measured: Day 1 to Day 36
PK parameter (CL/F)
Apparent plasma clearance
Measured: Day 1 to Day 36
PK parameter (Vz/F)
Apparent volume of distribution during the terminal phase
Measured: Day 1 to Day 36
Number of participants with adverse events (AEs)
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54
Number of participants with abnormal vital signs
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54
Number of participants with abnormal ECGs
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54
Number of participants with abnormal physical examination findings
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54
Number of participants with abnormal laboratory test results
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54
Number of participants with confirmed positive anti-drug antibody testing
Prevalence and incidence of ADAs to AZD6234 ADA titre
Measured: Day 1 to Day 54
Number of participants with serious adverse events (SAEs)
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Measured: Day 1 to Day 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202530 Sep 2025

First posted25 Feb 2025
Study start24 Feb 2025
Primary completion30 Sep 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Up to five cohorts (four renal impairment cohorts and controls with normal renal function) will be enrolled into the study. All subjects will receive the study intervention: * Cohort 1 will enroll participants with end stage renal disease * Cohort 2 will enroll participants with severe renal impairment * Cohort 3 will enroll healthy participants matched on a group level by sex, age, and BMI * Cohort 4 (optional) will enroll participants with moderate renal impairment * Cohort 5 (optional) will enroll participants with mild renal impairment
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06845813
Sponsor's protocol ID: D8750C00007
Status last verified: Oct 2025
First submitted: 24 Feb 2025
Last updated: 3 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234
ClinicalTrials.gov ID: NCT06845813
Acronym / sponsor ID: D8750C00007
Conditions: Renal Impairment
Keywords: Renal Impairment, Healthy Participants, AZD6234, Pharmacokinetics, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Feb 2025 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 25 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: Up to five cohorts (four renal impairment cohorts and controls with normal renal function) will be enrolled into the study. All subjects will receive the study intervention: * Cohort 1 will enroll participants with end stage renal disease * Cohort 2 will enroll participants with severe renal impairment * Cohort 3 will enroll healthy participants matched on a group level by sex, age, and BMI * Cohort 4 (optional) will enroll participants with moderate renal impairment * Cohort 5 (optional) will enroll participants with mild renal impairment

Arm	Type	Receives
Group 1	Experimental	Drug: AZD6234Subjects with end stage renal disease will receive a single subcutaneous dose of AZD6234 under fasted conditions
Group 2	Experimental	Drug: AZD6234Subjects with severe renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions
Group 3	Experimental	Drug: AZD6234Healthy participants will receive a single subcutaneous dose of AZD6234 under fasted conditions
Group 4 (optional)	Experimental	Drug: AZD6234Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions
Group 5 (optional)	Experimental	Drug: AZD6234Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participant must be 18 to 85 years of age, inclusive, at the time of signing the informed consent.
Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured at screening.
Participant 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.
Have an eGFR of ≥ 90 mL/min determined at screening.
Diagnosis of chronic kidney disease, stable renal function in the 3 months prior to dosing,

Key exclusion criteria (14 listed)

History or presence of: significant GI disease or previous upper GI surgery
Clinically significant cardiovascular disease, as judged by the investigator, d. Neuromuscular or neurogenic disease e. Severe vitamin D deficiency < 12 ng/dL.
History or presence of any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
History of psychosis, bipolar disorder
History of major depressive disorder within the past 2 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD6234Also: Dose 1Dose 1	Drug	Group 1, Group 2, Group 3, Group 4 (optional), Group 5 (optional)

Primary outcome

AUClast
Time frame: Day 1 to Day 36
Area under plasma concentration-time curve from time zero to the last measurable concentration
AUCinf
Time frame: Day 1 to Day 36
Area under plasma concentration-time curve from zero to infinity
Cmax
Time frame: Day 1 to Day 36
Maximum observed plasma concentration

11 secondary outcomes

Tmax
Time frame: Day 1 to Day 36
PK parameter (t1/2λz)
Time frame: Day 1 to Day 36
PK parameter (CL/F)
Time frame: Day 1 to Day 36
PK parameter (Vz/F)
Time frame: Day 1 to Day 36
Number of participants with adverse events (AEs)
Time frame: Day 1 to Day 54
Number of participants with abnormal vital signs
Time frame: Day 1 to Day 54
Number of participants with abnormal ECGs
Time frame: Day 1 to Day 54
Number of participants with abnormal physical examination findings
Time frame: Day 1 to Day 54
Number of participants with abnormal laboratory test results
Time frame: Day 1 to Day 54
Number of participants with confirmed positive anti-drug antibody testing
Time frame: Day 1 to Day 54
Number of participants with serious adverse events (SAEs)
Time frame: Day 1 to Day 54

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fadi Saba, M.D. principal investigator

Servico Integrado de Tecnicas Endovasculares

Thomas C Marbury, M.D. principal investigator

Servico Integrado de Tecnicas Endovasculares

Joel M Neutel, M.D. principal investigator

Servico Integrado de Tecnicas Endovasculares

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD6234 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast (time frame: Day 1 to Day 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.