This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of serious adverse events (SAEs)
Timeframe: Month 12
Incidence of treatment emergent adverse events (TEAEs)
Timeframe: Month 12
PK Parameter Cmax
Timeframe: Day 1, Month 3
PK Parameter Cmin
Timeframe: Day 1, Month 3
PK Parameter Tmax
Timeframe: Day 1, Month 3
AUC from 0-8 hours
Timeframe: Day 1, Month 3
AUC from 0 to 48 hours
Timeframe: Day 2
VEL-101 Accumulation Ratio
Timeframe: Month 3
VEL-101 Pre-Dose Serum Concentration
Timeframe: Day 1, Day 14, Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biospy)
Effect of Anti-Drug Antibody (ADA) Development on VEL-101 Serum Concentration
Timeframe: Months 1, 2, 3, 6, 9, 12, Periprocedural (kidney biopsy)
Effect of Neutralizing Antibody (NAb) Development on VEL-101 Serum Concentration
Timeframe: Day 1, Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)
VEL-101 CD28 Receptor Occupancy Concentration (%)
Timeframe: Days 1, 2, 3, 4, 5, 7, 14, 42, 70, 82, 91, 98 and Months 1, 2, 3, 6, 9, 12 and Periprocedural (kidney biopsy)