RituxiMab INDuction in Renal Transplantation

Conditions

• Function of Renal Transplant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  375mg/m\^2, single dose given 2-4 weeks prior to transplantation
• Tacrolimus — DRUG
  dose calculated to give levels of 3-7ng/ml
• Mycophenylate mofetil — DRUG
  Mycophenylate mofetil 2g/day in divided doses
• Hydrocortisone — DRUG
  100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
• Prednisolone — DRUG
  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.
• Prednisolone — DRUG
  Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.

Study Details

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.

Key Dates

Start date

Nov 30, 2010

Status verified

Jul 2020

Primary completion

Oct 31, 2020

Completion

Oct 31, 2022

Study Design

Enrollment

100 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
• Active Comparator: Control group
  Low dose tacrolimus with mycophenylate mofetil and continued prednisolone

Primary Outcome Measure

Estimated GFR (calculated using the Cockcroft-Gault formula) [ Time Frame: 1 year ]