A Study of TCD601 in de Novo Renal Transplant Recipients (ASCEND)

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)

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplantation
• Intervention / Treatment: Biological: TCD601; Biological: belatacept; Drug: MPA; Drug: Corticosteroids; Drug: ATG; Drug: TAC

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94143
      • University Of California San Francisco Medical Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCD601 (siplizumab); TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids	Biological: TCD601; Investigational Product; Other Names: siplizumab; Biological: belatacept; Study Product; Drug: MPA; Immunosuppression Therapy; Other Names: mycophenolic acid; Drug: Corticosteroids; Immunosuppression Therapy
Active Comparator: ATG; Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids	Drug: MPA; Immunosuppression Therapy; Other Names: mycophenolic acid; Drug: Corticosteroids; Immunosuppression Therapy; Drug: ATG; Comparator; Other Names: antithymocyte globulin; Drug: TAC; Comparator; Other Names: tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function in Arm 1 compared to Arm 2	renal function using estimated glomerular filtration rate (eGFR)	12 months

Collaborators and Investigators

• Sponsor: ITB-Med LLC
• Investigators: Study Director: Fredrik Juhlin, ITB-Med LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunoconjugates; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Biological Products; Complex Mixtures; Caproates; Immune Sera; Abatacept; Mycophenolic Acid; Tacrolimus; Antilymphocyte Serum; Adrenal Cortex Hormones; siplizumab
• Other Study ID Numbers: TCD601B203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No