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 (26) 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
United States
Massachusetts
Brigham & Women's Hospital- Site Number : 8400049
RECRUITING
Boston
New York
Montefiore Medical Center - Moses Campus- Site Number : 8400006
RECRUITING
The Bronx
Other Locations
Argentina
Investigational Site Number : 0320001
RECRUITING
Corrientes
Australia
Investigational Site Number : 0360002
RECRUITING
Adelaide
Investigational Site Number : 0360001
RECRUITING
Parkville
Investigational Site Number : 0360003
RECRUITING
Sydney
Belgium
Investigational Site Number : 0560002
RECRUITING
Brussels
Chile
Investigational Site Number : 1520004
RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Santiago
China
Investigational Site Number : 1560003
RECRUITING
Chengdu
Investigational Site Number : 1560012
RECRUITING
Jinan
Investigational Site Number : 1560017
RECRUITING
Nanchang
Investigational Site Number : 1560008
RECRUITING
Nanning
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560011
RECRUITING
Tianjin
Investigational Site Number : 1560006
RECRUITING
Wuhan
Investigational Site Number : 1560005
RECRUITING
Zhengzhou
Investigational Site Number : 1560009
RECRUITING
Zhengzhou
Denmark
Investigational Site Number : 2080001
RECRUITING
Aarhus
Israel
Investigational Site Number : 3760002
RECRUITING
Ramat Gan
Italy
RECRUITING
Torette
Spain
Investigational Site Number : 7240001
RECRUITING
Barcelona
Investigational Site Number : 7240007
RECRUITING
Barcelona
Investigational Site Number : 7240003
RECRUITING
L'hospitalet De Llobregat
Investigational Site Number : 7240005
RECRUITING
Málaga
United Kingdom
Investigational Site Number : 8260001
RECRUITING
Birmingham
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
The first dose of frexalimab will be given intravenously and subsequent doses of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)