A Phase 2, Randomized, Partially Blinded, Controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VEL-101 in Kidney Transplant Recipients.
Veloxis Pharmaceuticals
Summary
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Description
This study is a randomized, multicenter, partially blinded, active control study to evaluate the safety and effectiveness of VEL-101 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1:1 to receive either VEL-101 (low dose or high dose) or tacrolimus.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Greater than or equal to 18 years of age 2. Able to understand key components of the study as described in the written informed consent document and willing and able to provide written informed consent. 3. If female, surgically sterile (post hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), postmenopausal (greater than 12 months of amenorrhea without alternative medical causes), or, if of childbearing potential, is using a highly effective contraception until 90 days after EOS visit. 4. If male, is vasectomized, has undergone bilateral orchidectomy, agr…
Interventions
- DrugTacrolimus (TAC)
Tacrolimus Immediate Release in addition to SOC
- DrugVEL-101
VEL-101 in addition to SOC
Location
- USA Site #1087Dallas, Texas