About this trial
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Eligibility criteria
Qualifiers
Greater than or equal to 18 years of age
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.
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.
If male, is vasectomized, has undergone bilateral orchidectomy, agrees to abstinence of heterosexual intercourse, or only has female partner using highly effective contraception, surgically sterile or postmenopausal and agrees to use method until 90 days after EOS visit.
Disqualifiers
Negative for EBV or Epstein-Barr nuclear antigen antibody
Know allergy to study medication (rATG, corticosteroids, MMF, tacrolimus, or VEL-101) or its components or a history of a severe allergic reaction to any drug.
History of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell or bone marrow transplant.
Planned multiorgan transplant, including dual or en-bloc kidney transplant
Trial design
Treatments tested in this trial
- Tacrolimus (TAC)
- VEL-101