A randomized trial of Rituximab in induction therapy for living donor renal transplantation - Randomized trial of rituximab in renal transplantatio

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]; End stage renal disease; MedDRA version: 17.0Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical procedures; renal function after renal transplantation

• Registration Number: EUCTR2009-017066-23-GB
• Lead Sponsor: Guys and St Thomas Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
If female and of child bearing potential, taking adequate contraception.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Previous other organ transplants lost through acute rejection
Patients undergoing antibody removal.
Patients with other organ transplants.
Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab.
Patients with white cell count below 3.6x10^9/L; Inclusion of patients with white blood cell counts less than 4.0x10^9/L, but higher than 3.6x10^9/L will be left to the discretion of the Principal Investigator.
Patients with platelet count below 100x10^9/L
Patients who are treated with drugs that are known to have clinically significant interactions with tacrolimus and those treated with 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.
Prisoners or young offenders.
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can the addition of rituximab to a minimalist immunosuppressive regimen allow further reduction in immunosuppression?;Secondary Objective: Are rejection rates lower and is graft function better after 1 year in patients given rituximab?<br>Are immune responses to the donor decreased after rituximab, particularly the response mediated by the T cells and B cells?<br>;Primary end point(s): eGFR (using the MDRD calculation) at 12 months after transplantation