Status:
COMPLETED
Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients
Lead Sponsor:
Martina McGrath, MD
Conditions:
Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 sotagliflo...
Eligibility Criteria
Inclusion
- Adults ≥18 years
- Recipients of kidney transplant with stable eGFR\*
- eGFR-creatinine (CKD-EPI 2021) ≥25 mL/min/1.73 m2
- Informed consent
- Stable eGFR will be ascertained by careful chart review establishing that the patient's current graft has been functioning for at least 12 months post-transplantation, patients have not been treated for acute rejection within the prior 3 months, and a creatinine-based eGFR is stable (two consecutive measurements separated by at least 28 days within 5 mL/min/1.73 m2) and ≥25 mL/min/1.73 m2.
Exclusion
- Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis)
- Biopsy-proven acute rejection within 12 weeks
- Screening serum potassium \>5.5 mmol/L
- Uncontrolled hypertension (systolic blood pressure \>180/100 mmHg)
- New York Heart Association (NYHA) Class IV HF
- Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
- History of diabetic ketoacidosis
- Type 1 Diabetes Mellitus
- Hereditary glucose-galactose malabsorption or primary renal glucosuria
- Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease
- Malignancy within 5 years (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
- Human immunodeficiency virus antibody positive
- Major surgery within 12 weeks
- Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
- Combination use of ACEi and ARB
- Current use of an SGLT2 inhibitor (within 12 weeks prior to randomization)
- Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
- Digoxin plasma level \>1.2 ng/mL
- Clofibrate, fenofibrate, dronedarone, or ranolazine treatment that has not been at a stable dose in the 30 days prior to screening or randomization, or a dose adjustment is expected
- Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
- Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
- Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy
- Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05405556
Start Date
October 17 2022
End Date
November 16 2024
Last Update
February 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's
Boston, Massachusetts, United States, 02115