Envarsus in Delayed Graft Function (E-DGF)

Phase 4 Completed 100 enrolled University of Wisconsin, Madison Veloxis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.

Timeline

Start: 2019-03-18
Primary completion: 2022-07-22
Completion: 2022-07-22

Publications

Parajuli S, Bloom M, Mandelbrot D, Astor BC. Serum beta2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients. Clin Transplant. 2024 Aug;38(8):e15435. doi: 10.1111/ctr.15435.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tacrolimus	Small molecule	—	Oral
Comparator	Tacrolimus	Small molecule	—	—

Indications

No indication recorded.