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Completed

NCT Number: NCT04311632

A Dose Escalation Study in de Novo Renal Transplantation

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCD601

Biological

Investigational Product

Tacrolimus (TAC)

Drug

Standard of Care Concomitant Immunosuppression

Corticosteroids (CS)

Drug

Standard of Care Concomitant Immunosuppression

Mycophenolate Mofetil (MMF)

Drug

Standard of Care Concomitant Immunosuppression

ATG

Drug

Standard of Care induction therapy in solid organ transplantation

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.

    Time frame: 12 months

  2. Measure Peak Plasma Concentration (Cmax) Over Time.

    Time frame: 12 months

    The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.

  3. Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).

    Time frame: 12 months

    The AUC from time zero to the last measurable concentration sampling time.

Secondary outcomes

  1. The Incidence of Rejection at 12 Months Post-transplant.

    Time frame: 12 months

    The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.

  2. To Assess the Change in Renal Function Over Time.

    Time frame: 12 months

    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).

Sponsors and collaborators

Lead sponsor

ITB-Med LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2020
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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