A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation
Phase 1
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Renal Transplantation
Both
Renal Transplantation
Trial Information
A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation
Inclusion Criteria:
- Patients aged 18 years or above
- Recipients of first or second renal transplants
- Recipients of kidneys 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
Exclusion Criteria:
- Patients receiving other immunosuppressive therapy within the preceding 28 days
- Recipients of HLA-identical sibling kidneys
- Patients with flow-PRA >50% within 6 months prior to enrolment
- Recent history of malignancy
- Active infection
- Pregnant or lactating females
- Women of childbearing potential not willing to use reliable form of contraception
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
Principal Investigator
Gunnar E Tydén, Professor
Investigator Role:
Study Director
Investigator Affiliation:
Karolinska Institutet
Authority:
Sweden: Medical Products Agency
Study ID:
Eudra CT: 2005-001231-29
NCT ID:
NCT00255593
Start Date:
November 2005
Completion Date:
October 2007
Related Keywords:
- Renal Transplantation
- Kidney
- Transplantation
- Immunosuppression
- Rituximab
Name | Location |
|---|
