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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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2022-10-17
Est. Completion 2024-11-16
Phase Phase 2

Sponsor

Martina McGrath, MD

1 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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