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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05405556
The ClinicalTrials.gov registry entry for NCT05405556 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (98% lower). The listed sponsor is Martina McGrath, MD, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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