A Dose Escalation Study in de Novo Renal Transplantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-10-03

Brief Summary

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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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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Group Type EXPERIMENTAL

TCD601

Intervention Type BIOLOGICAL

Investigational Product

Tacrolimus (TAC)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Corticosteroids (CS)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Mycophenolate Mofetil (MMF)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Arm 2

TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Group Type EXPERIMENTAL

TCD601

Intervention Type BIOLOGICAL

Investigational Product

Tacrolimus (TAC)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Corticosteroids (CS)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Mycophenolate Mofetil (MMF)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Arm 3

ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Group Type ACTIVE_COMPARATOR

Tacrolimus (TAC)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Corticosteroids (CS)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

Mycophenolate Mofetil (MMF)

Intervention Type DRUG

Standard of Care Concomitant Immunosuppression

ATG

Intervention Type DRUG

Standard of Care induction therapy in solid organ transplantation

Interventions

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TCD601

Investigational Product

Intervention Type BIOLOGICAL

Tacrolimus (TAC)

Standard of Care Concomitant Immunosuppression

Intervention Type DRUG

Corticosteroids (CS)

Standard of Care Concomitant Immunosuppression

Intervention Type DRUG

Mycophenolate Mofetil (MMF)

Standard of Care Concomitant Immunosuppression

Intervention Type DRUG

ATG

Standard of Care induction therapy in solid organ transplantation

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No