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NCT05490511 · ClinicalTrials.gov registry record · Phase 1
Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus
A Phase 1 study of CBD and Kidney Disease, Chronic, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT05490511: Completed Phase 1 study of CBD and Kidney Disease, Chronic, sponsored by Indiana University.
NCT05490511 is a Phase 1 study of CBD and Kidney Disease, Chronic that has completed, run by Indiana University. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 8 other CBD trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05490511, a Phase 1 study of CBD and Kidney Disease, Chronic, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.
Primary Outcome
The primary outcome is the AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone between CYP3A5 expressers and non-expressers in subjects with and without chronic kidney disease (CKD). Subjects with and without CKD will be analyzed separately.
Conditions Studied
Interventions
- DRUG Tacrolimus single dose
- DRUG Epidiolex single dose
- DRUG Epidiolex steady-state and tacrolimus single dose
Study Locations (1)
Indiana
- IU Health University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 1 |
What the finished NCT05490511 record still lists
NCT05490511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 8 other CBD trials with a reported enrollment target.
The record links to 3 conditions, with CBD appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus single dose is the first listed.
NCT05490511 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05490511 about?
NCT05490511 is a clinical study titled "Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus". The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.
What is the current status of trial NCT05490511?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2022-10-31. Estimated completion is 2025-08-31.
What conditions does trial NCT05490511 study?
This clinical trial studies the following conditions: CBD, Kidney Disease, Chronic, Transplant Complication.
What interventions are being tested in trial NCT05490511?
The interventions under investigation include: Tacrolimus single dose (DRUG), Epidiolex single dose (DRUG), Epidiolex steady-state and tacrolimus single dose (DRUG).
Who is sponsoring clinical trial NCT05490511?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05490511 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for CBD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05490511's enrollment target sits among peer trials
57 6th of 8 higher than 3 of 8 other CBD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other CBD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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