NCT05669001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

December 20, 2022

Last Update Submit

May 4, 2026

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2

    The number of adverse events and serious adverse events

    12 months

Secondary Outcomes (1)

  • Renal function in Arm 1 compared to Arm 2

    12 months

Study Arms (2)

TCD601 (siplizumab)

EXPERIMENTAL

TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids

Biological: TCD601Biological: belataceptDrug: MPADrug: Corticosteroids

ATG

ACTIVE COMPARATOR

Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids

Drug: ATGDrug: TACDrug: MPADrug: Corticosteroids

Interventions

TCD601BIOLOGICAL

Investigational Product

Also known as: siplizumab
TCD601 (siplizumab)
belataceptBIOLOGICAL

Study Product

TCD601 (siplizumab)
ATGDRUG

Comparator

Also known as: antithymocyte globulin
ATG
TACDRUG

Comparator

Also known as: tacrolimus
ATG
MPADRUG

Immunosuppression Therapy

Also known as: mycophenolic acid
ATGTCD601 (siplizumab)
CorticosteroidsDRUG

Immunosuppression Therapy

ATGTCD601 (siplizumab)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia Health

Charlottesville, Virginia, 22903, United States

Location

Inova Fairfax Hospital Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Interventions

siplizumabAbataceptAntilymphocyte SerumTacrolimusMycophenolic AcidAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsImmune SeraImmunoproteinsBiological ProductsComplex MixturesMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Fredrik Juhlin

    ITB-Med LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

December 30, 2022

Study Start

December 28, 2023

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(18)