Live donor renal transplantation Surgery
Conditions
Interventions
Pre-medication with paracetamol 1 g orally (PO), hydrocortisone 100 mg intravenously (IV) and chlorphenamine 10 mg IV is provided 30 minutes before start of rituximab infusion. A single dose of rituxi
Sponsors
Guy's and St Thomas' Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged over 18 years, either sex 2. Receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection 3. Have given written informed consent
Exclusion criteria
Exclusion criteria: Amendments as of 22/12/2010: Point 8 of the below exclusion criteria has been amended to read as follows: 8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant Initial information at time of registration: 1. Previous other organ transplants lost through acute rejection 2. Patients undergoing antibody removal 3. Patients with other organ transplants 4. Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab 5. Patients with white cell count below 4,500/mm^3 6. Patients with platelet count below 1,500/mm^3 7. Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin 8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 30 days prior to transplant 9. Pregnant or breastfeeding women 10. 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 11. Patients known to be human immunodeficiency virus (HIV), hepatitis B or C surface antigen positive 12. Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate (GFR) (Modification of Diet in Renal Disease [MDRD] study calculation) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biopsy proven acute rejection, graft and patient survival at 1 year 2. Infections 3. Post-transplant lymphoproliferative disorder (PTLD) | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed