RituxiMab INDuction in Renal Transplantation

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborator: Astellas Pharma Europe Ltd.
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Tacrolimus

Criteria

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