NCT01095172

RituxiMab INDuction in Renal Transplantation

A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Function of Renal Transplant

Interventions

Type	Name	Description
DRUG	Rituximab	375mg/m\^2, single dose given 2-4 weeks prior to transplantation
DRUG	Tacrolimus	dose calculated to give levels of 3-7ng/ml
DRUG	Mycophenylate mofetil	Mycophenylate mofetil 2g/day in divided doses
DRUG	Hydrocortisone	100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
DRUG	Prednisolone	Prednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none.
DRUG	Prednisolone	Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.

Timeline

• Start date: 2010-11-01
• Primary completion: 2020-10-01
• Completion: 2022-10-01
• First posted: 2010-03-30
• Last updated: 2020-07-22

Locations

6 sites across 1 country: United Kingdom