CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Transplantation

Treatments: Drug: Mycophenolate mofetil (MMF); Drug: Tacrolimus (Tac); Biological: CFZ533; Biological: anti-IL2 Induction; Drug: Corticosteroids (CS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02217410

CCFZ533X2201

Details and patient eligibility

About

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.
• Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
• Recipients of a kidney with a cold ischemia time (CIT) < 30 hours.

Main Exclusion Criteria:

• Recipients of an organ from a non-heart beating donor.
• ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
• Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.
• Subjects at high immunological risk for rejection
• Subjects at risk for tuberculosis (TB)
• Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.
• Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Regimen A

Experimental group

Description:

CFZ533 administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Treatment:

Biological: CFZ533

Drug: Corticosteroids (CS)

Drug: Tacrolimus (Tac)

Drug: Mycophenolate mofetil (MMF)

Regimen B

Experimental group

Description:

CFZ533 administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction

Treatment:

Biological: CFZ533

Drug: Corticosteroids (CS)

Drug: Mycophenolate mofetil (MMF)

Biological: anti-IL2 Induction

Regimen C

Active Comparator group

Description:

Standard of care (SoC) \[concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction\]

Treatment:

Drug: Corticosteroids (CS)

Drug: Tacrolimus (Tac)

Drug: Mycophenolate mofetil (MMF)

Biological: anti-IL2 Induction