Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.

• Participants with low to moderate immunological risk.

Locations
Other Locations
Australia
Investigational Site Number : 0360003
RECRUITING
Sydney
China
Investigational Site Number : 1560001
RECRUITING
Shanghai
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2026-03-13
Estimated Completion Date: 2033-08-15
Participants
Target number of participants: 526
Treatments
Experimental: Frexalimab
Frexalimab
Active_comparator: Tacrolimus
Tacrolimus
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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