Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 26, 2018

Primary Completion Date

July 17, 2020

Study Completion Date

July 17, 2021

Conditions
Renal Transplant RejectionKidney Transplant Failure and Rejection
Interventions
DRUG

Tacrolimus Extended Release Oral Tablet

Tacrolimus, extended-release, oral (Envarsus); 0.75 mg, 1 mg, 4 mg tablets will be administered once daily at initial weight-based dose of 0.12 mg/kg.

DRUG

Tacrolimus

Tacrolimus immediate-release, oral; 0.5 mg, 1 mg, 5 mg capsules will be administered twice daily per clinical judgment of supervising physician

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Veloxis Pharmaceuticals

INDUSTRY

lead

Columbia University

OTHER

NCT03511560 - Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation | Biotech Hunter | Biotech Hunter