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A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

NCT07412470 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2026-05-20

No results posted yet for this study

Summary

The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include:

* The study and treatment duration will be up to approximately 5 years.
* The number of visits will be approximately 38.

Conditions

  • Kidney Transplant Rejection

Interventions

DRUG

Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:IV

DRUG

Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC

DRUG

Tacrolimus

Pharmaceutical form:Capsule-Route of administration:Oral

DRUG

rabbit anti-thymocyte globulin

Pharmaceutical form:Solution for injection-Route of administration:IV

DRUG

mycophenolate mofetil

Pharmaceutical form:Tablet or capsule-Route of administration:Oral

DRUG

mycophenolate sodium

Pharmaceutical form:Tablet-Route of administration:Oral

DRUG

methylprednisolone

Pharmaceutical form:Solution for injection-Route of administration:IV

DRUG

prednisone

Pharmaceutical form:Tablet-Route of administration:Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2029-08-15
Completion
2033-08-15
FDA Drug
Yes

Countries

  • Australia
  • Chile
  • China
  • Denmark
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412470 on ClinicalTrials.gov