NCT03511560

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

To Understand the Impact of Immunosuppression Using Once-per-day Envarsus XR on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney outcomes, including graft loss and patient death. Patients will be followed for up to 1 year during the open-label study period.

Detailed description

Despite lower rates of acute rejection and short-term improvements in patient and graft survival, the rate of late allograft loss following kidney transplantation has remained unchanged. Achievement of therapeutic, minimally toxic, tacrolimus concentrations early (within 30 days), after transplantation, is known to be important since achieving it has been associated with a lowered risk of acute rejection. The investigators hypothesize that using extended release tacrolimus (Envarsus XR, Veloxis), will provide more stable, more effective, and less toxic levels of tacrolimus in renal allograft recipients. Therefore, the investigators propose to analyze the impact of the blood concentration normalized by the dose (C/D ratio) on kidney function after renal transplantation in experimental group that will be treated with Envarsus XR and the standard of care (SOC) group treated with twice a day tacrolimus.

Conditions

• Renal Transplant Rejection
• Kidney Transplant Failure and Rejection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-26
• Primary completion: 2020-07-17
• Completion: 2021-07-17
• First posted: 2018-04-30
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study