A PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED, MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF RITUXIMAB AS INDUCTION THERAPY TOGETHER WITH TACROLIMUS, MYCOPHENOLATE MOFETIL AND STEROIDS FOR PATIENTS UNDERGOING RENAL TRANSPLANTATIO

• Conditions: Chronic renal failure patients who are receiving a kidney transplant. Different immunosuppressive protocls are awailable. However, current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-cell mediated processes. However, there is an increasing evidence that B cells may significantly contribute to post-transplant morbidity in addition to their role in acute humoral rejection.

• Registration Number: EUCTR2005-001231-29-SE
• Lead Sponsor: Dept of Transplantation Surgery B 56, Karolinska University Hospital, Huddinge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patients aged 18 years or above
Recipients of first or second renal transplant
Recipients from living or cadaveric donors
Single organ recipients (kidney only)
Patients providing written informed consent
Patients cooperative and able to complete all the assessment procedures

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

Exclusion Criteria

HLA-identical siblings
Patients receiving immunosuppressive therapy within the preceding 28 days
PRA >50% within 6 months prior to enrolment
Previous exposure to murine antibodies
History of malignancy (except localised non-melanotic skin cancer) or the presence of any active malignancy at the time of transplant
Active infection (HCV, HBV, HIV)
Pregnant or lactating females
Women of child bearing potential not willing to use reliable form of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified