A Dose Escalation Study in de Novo Renal Transplantation

ITBMed

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: Corticosteroids (CS); Drug: ATG; Drug: Mycophenolate Mofetil (MMF); Biological: TCD601; Drug: Tacrolimus (TAC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04311632

TCD601B102

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus (TAC)

Biological: TCD601

Drug: Mycophenolate Mofetil (MMF)

Drug: Corticosteroids (CS)

Arm 2

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus (TAC)

Biological: TCD601

Drug: Mycophenolate Mofetil (MMF)

Drug: Corticosteroids (CS)

Arm 3

Active Comparator group

Description:

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

Treatment:

Drug: Tacrolimus (TAC)

Drug: Mycophenolate Mofetil (MMF)

Drug: ATG

Drug: Corticosteroids (CS)