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ASCEND: A Study of TCD601 in de Novo Renal Transplant Recipients

Sponsor
ITB-Med LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05669001
Collaborator
(none)
90
Enrollment
2
Arms
29
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

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: Arm 2

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

    Drug: ATG
    Comparator
    Other Names:
  • antithymocyte globulin

    • Drug: TAC
    Comparator
    Other Names:
  • tacrolimus

    • Drug: MPA
    Immunosuppression Therapy
    Other Names:
  • mycophenolic acid

    • Drug: Corticosteroids
    Immunosuppression Therapy

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 [12 months]

      The number of adverse events and serious adverse events

    Secondary Outcome Measures

    1. Renal function in Arm 1 compared to Arm 2 [12 months]

      renal function using estimated glomerular filtration rate (eGFR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ITB-Med LLC

    Investigators

    • Study Director: Kellie Kennon, BSN, ITB-Med LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ITB-Med LLC
    ClinicalTrials.gov Identifier:
    NCT05669001
    Other Study ID Numbers:
    • TCD601B203
    First Posted:
    Dec 30, 2022
    Last Update Posted:
    Dec 30, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Abatacept
    Tacrolimus
    Antilymphocyte Serum

    Study Results

    No Results Posted as of Dec 30, 2022