drugset / Trial / NCT03321656
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
RandomizedParallel-groupOpen-labelTreatment
Summary
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Timeline
- Start
- 2019-03-28
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | 0.07 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.14 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.2 mg/kg | Oral |