Kidney patients needed for drug dosing study
NCT ID NCT06845813
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how different levels of kidney function affect the way the body processes a single dose of the drug AZD6234. Researchers compared 24 adults with various degrees of kidney impairment to healthy volunteers. The goal was to understand how the drug moves through the body and whether it is safe, which will help guide future dosing recommendations for people with kidney disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD6234
- What this could lead to
- If successful, this study could help doctors determine the right dose of AZD6234 for people with kidney problems, making the drug safer and more effective for them.
- What could go wrong
- This is a very early (Phase 1) study with only 24 participants, so results may not apply to everyone. The drug's safety and effectiveness for treating any condition are not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: * 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. Exclusion Criteria: \- 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Lake Forest, California, 92630, United States
-
Research Site
Orlando, Florida, 32808, United States
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Research Site
Orlando, Florida, 32809, United States
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