VEL-101 to Prevent Rejection After Kidney Transplantation

Conditions

• Transplantation, Kidney

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tacrolimus (TAC) — DRUG
  Tacrolimus Immediate Release in addition to SOC
• VEL-101 — DRUG
  VEL-101 in addition to SOC

Study Details

This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.

Key Dates

First listed

Dec 18, 2025

Start date

Aug 18, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VEL-101 Low Dose
  VEL-101 Low Dose
• Experimental: VEL-101 High Dose
  VEL-101 High Dose
• Active Comparator: Tacrolimus
  Tacrolimus

Primary Outcome Measure

Incidence of serious adverse events (SAEs) [ Time Frame: Month 12 ]

Central Contacts

• Study Director
  844-835-6947 or 1-984-309-4040
  [email protected]

Locations (1)

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