NCT05405556

Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Martina McGrath, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Kidney Transplant

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	eGFR reporting	To test the proportion of patients successfully completing the protocol according to different eGFR reporting strategies, randomization in a 1:1 fashion at the patient level (n=50) will occur as follows: 1. only study-related eGFR values \>25% below baseline will be reported to patients and providers 2. all study-related eGFR will be provided to patients and providers

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-05-10
• Completion: 2024-11-16
• First posted: 2022-06-06
• Last updated: 2025-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study