Clinical trial NCT05669001: A Study of TCD601 in de Novo Renal Transplant Recipients
Official title: A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Renal Transplantation
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Male or female patients ≥ 18 to 70 years of age
* Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor

Key Exclusion Criteria:

* Subjects who have received a kidney allograft previously
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death

Primary outcomes:
measure: The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
timeFrame: 12 months
Secondary outcomes:
measure: Renal function in Arm 1 compared to Arm 2
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis (Barnes-Jewish Hospital)
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital Medical Campus
state: Virginia
Study officials:
affiliation: ITB-Med LLC
name: Nick Hryciw, BS, MA
role: STUDY_DIRECTOR
References: