RituxiMab INDuction in Renal Transplantation (ReMIND)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Unknown; Phase 4

Conditions: Function of Renal Transplant

Treatments: Drug: Hydrocortisone; Drug: Prednisolone; Drug: Mycophenylate mofetil; Drug: Rituximab; Drug: Tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01095172

9154 (Registry Identifier)

2009-017066-23 (EudraCT Number)

RituxiRT

95769119 (Registry Identifier)

Details and patient eligibility

About

Hypothesis:

• That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.

Aim:

• To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.

Objectives:

• To assess whether B cell depletion affects graft function, acute rejection and complication rates
• To assess whether the T cell response to allotransplantation is impaired by B cell depletion.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
• Patients who have given written informed consent
• Women of child bearing potential taking adequate contraception.

Exclusion criteria

• Previous other organ transplants lost through acute rejection
• Patients undergoing antibody incompatible transplantation
• Patients with other organ transplants
• Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
• Patients with white cell count below 4.0x10^9/L.
• Patients with platelet count below 100x10^9/L
• Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
• Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
• Pregnant or breastfeeding women
• Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
• Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
• Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
• Women of child bearing potential not willing to take adequate contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rituximab

Experimental group

Description:

Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone

Treatment:

Drug: Tacrolimus

Drug: Prednisolone

Drug: Rituximab

Drug: Mycophenylate mofetil

Drug: Prednisolone

Drug: Hydrocortisone

Control group

Active Comparator group

Description:

Low dose tacrolimus with mycophenylate mofetil and continued prednisolone

Treatment:

Drug: Tacrolimus

Drug: Prednisolone

Drug: Mycophenylate mofetil

Drug: Prednisolone

Drug: Hydrocortisone