A Dose Escalation Study in de Novo Renal Transplantation

A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATG

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 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 unrelated, or non-HLA identical living related donor.
• Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.

Key Exclusion Criteria:

• Multiple-organ transplant recipients
• 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
• Subjects at high immunological risk for rejection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Experimental: Arm 2; TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Active Comparator: Arm 3; ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression; Drug: ATG; Standard of Care induction therapy in solid organ transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.		12 months
Measure Peak Plasma Concentration (Cmax) Over Time.	The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.	12 months
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).	The AUC from time zero to the last measurable concentration sampling time.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Rejection at 12 Months Post-transplant.	The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.	12 months
To Assess the Change in Renal Function Over Time.	Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant).	12 months

Collaborators and Investigators

• Sponsor: ITB-Med LLC
• Investigators: Study Director: Nick Hryciw, MA, ITB-Med LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Calcineurin Inhibitors; Mycophenolic Acid; Tacrolimus
• Other Study ID Numbers: TCD601B102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No