A Phase 2, randomized, partially blinded, controlled, doseranging study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VEL-101 in kidney transplant recipients. (RENGEVITY-201)
| Sponsor: |
Veloxis Pharmaceuticals, Inc. |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
ACYY0969 |
| U.S. Govt. ID: |
NCT07290777 |
| Contact: |
Transplant Clinical Research Center: 212-305-3839 / tcrcstudyreferral@cumc.columbia.edu |
The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be followed for 12 months, with the possibility of extending treatment beyond 12 months. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Lloyd Ratner, MD, MPH, FACS
| Are you at least 18 years old? |
Yes |
No |
| Are you on the kidney transplant waiting list? |
Yes |
No |