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NCT05405556 · ClinicalTrials.gov registry record · Phase 2
Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients
A Phase 2 study of Kidney Transplant, sponsored by Martina McGrath, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05405556: Completed Phase 2 study of Kidney Transplant, sponsored by Martina McGrath, MD.
NCT05405556 is a Phase 2 study of Kidney Transplant that has completed, run by Martina McGrath, MD. The registered enrollment target is 40 participants, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05405556, a Phase 2 study of Kidney Transplant, has completed, sponsored by Martina McGrath, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an investigator-initiated, randomized controlled trial in adult KTRs (N=50) with stable allograft function to assess: 1) the reversibility of the expected acute changes in eGFR with sotagliflozin (donated by Lexicon); 2) proportion of patients completing the protocol according to different eGFR reporting strategies (using a predefined algorithm to manage the expected pharmacological effect of sotagliflozin on eGFR); 3) safety and tolerability of sotagliflozin.
Primary Outcome
Following 12 weeks of open-label drug treatment, participants will stop drug and be followed for a further four weeks (16 weeks total). Reversibility will be assessed as the proportion of patients who return to baseline eGFR (+/- 10%) by the end of the 4-week off-treatment period.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST eGFR reporting
Study Locations (1)
Massachusetts
- Brigham and Women's - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-10-17 |
| Est. Completion | 2024-11-16 |
| Phase | Phase 2 |
What the finished NCT05405556 record still lists
NCT05405556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Kidney Transplant appearing as the primary indexed condition, and to 1 intervention - of which eGFR reporting is the first listed.
NCT05405556 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05405556 about?
NCT05405556 is a clinical study titled "Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients". This is an investigator-initiated, randomized controlled trial in adult KTRs (N=50) with stable allograft function to assess: 1) the reversibility of the expected acute changes in eGFR with sotagliflozin (donated by Lexicon); 2) proportion of patients completing the protocol according to different e...
What is the current status of trial NCT05405556?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-10-17. Estimated completion is 2024-11-16.
What conditions does trial NCT05405556 study?
This clinical trial studies the following conditions: Kidney Transplant.
What interventions are being tested in trial NCT05405556?
The interventions under investigation include: eGFR reporting (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05405556?
This trial is sponsored by Martina McGrath, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05405556 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant
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 NCT05405556's enrollment target sits among peer trials
40 19th of 30 higher than 12 of 30 other Kidney Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant 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.
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