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120 Participants NeededMy employer runs this trial

VEL-101 for Kidney Transplant

(RENGEVITY-201 Trial)

SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Veloxis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults (18+) getting a kidney transplant from either a deceased or certain living donors. Participants must be able to follow study procedures, use effective birth control if needed, and have up-to-date vaccinations. People with recent failed transplants due to rejection or recurrent disease in the first year can't join.

Inclusion Criteria

6. Able \& willing to comply with all study procedures, including PK and PD assessments, as assessed by the Investigator 7. Vaccination up to date per the center's SOC as assessed by the Investigator.
I can follow the study's requirements as per my doctor's opinion.
I am 18 years old or older.
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What Are the Treatments Tested in This Trial?

Interventions

  • Tacrolimus
  • VEL-101

Trial Overview

The study compares VEL-101, a new medication, against tacrolimus (a standard anti-rejection drug) to see which better prevents organ rejection after kidney transplantation. Participants are randomly assigned to one of the two treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: VEL-101 Low DoseExperimental Treatment1 Intervention
Group II: VEL-101 High DoseExperimental Treatment1 Intervention
Group III: TacrolimusActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Veloxis Pharmaceuticals

Lead Sponsor

Trials
43
Recruited
3,200+

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