RituxiMab INDuction in Renal Transplantation
- Conditions
- Function of Renal Transplant
- Interventions
- Registration Number
- NCT01095172
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab Mycophenylate mofetil Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone Rituximab Hydrocortisone Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone Control group Tacrolimus Low dose tacrolimus with mycophenylate mofetil and continued prednisolone Control group Mycophenylate mofetil Low dose tacrolimus with mycophenylate mofetil and continued prednisolone Control group Hydrocortisone Low dose tacrolimus with mycophenylate mofetil and continued prednisolone Control group Prednisolone Low dose tacrolimus with mycophenylate mofetil and continued prednisolone Rituximab Rituximab Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone Rituximab Tacrolimus Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone Rituximab Prednisolone Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
- Primary Outcome Measures
Name Time Method Estimated GFR (calculated using the Cockcroft-Gault formula) 1 year
- Secondary Outcome Measures
Name Time Method Biopsy proven acute rejection (based on Banff classification) 1, 2, 3, 4, 5 years Allograft survival 1, 2, 3, 4, 5 years Patient Survival 1, 2, 3, 4, 5 years Infection rate 1 year New episodes, including (but not restricted to) viral (e.g. CMV, EBV), bacterial (e.g. Urinary Tract Infections with details of causative organism) and fungal infections will be recorded at each assessment time-point.
Changes in B and T cell repertoire 1 year
Trial Locations
- Locations (6)
Central Manchester University Hospitals NHS Foundation Trust
🇬🇧Manchester, United Kingdom
East Kent Hospitals NHS Foundation Trust
🇬🇧Canterbury, Kent, United Kingdom
Glasgow Renal and Transplant Unit
🇬🇧Glasgow, United Kingdom
Sheffield Kidney Institute
🇬🇧Sheffield, United Kingdom
South West Transplant Centre
🇬🇧Plymouth, Devon, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom