A Prospective Randomized Study on the Efficacy and Safety of the Prophylactic Use of Rituximab, Added to Standard Immunosuppressive Treatment in Comparison With Standard Immunosuppressive Treatment Alone in Renal Transplantation
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Transplantation
Both
Kidney Transplantation
Trial Information
A Prospective Randomized Study on the Efficacy and Safety of the Prophylactic Use of Rituximab, Added to Standard Immunosuppressive Treatment in Comparison With Standard Immunosuppressive Treatment Alone in Renal Transplantation
Inclusion Criteria:
- Renal transplant recipients
- Signed, dated, and witnessed IRB approved informed consent
Exclusion Criteria:
- Pregnancy
- Living donor, who is HLA identical.
- Hemolytic uremic syndrome as original kidney disease.
- Focal segmental glomerulosclerosis that had recurred in a previous graft.
- More than two previously failed grafts and/or PRA > 85%.
- Previous treatment with anti-CD20 antibodies.
- Diabetes mellitus that is currently not treated with insulin.
- Total white blood cell count <3,000/mm3 or platelet count <75,000/mm3.
- Active infection with hepatitis B, hepatitis C, or HIV.
- History of tuberculosis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence and severity of biopsy-confirmed acute rejection
Outcome Time Frame:
First six months after transplantation
Safety Issue:
No
Principal Investigator
Luuk Hilbrands, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
RRT06
NCT ID:
NCT00565331
Start Date:
December 2007
Completion Date:
June 2015
Related Keywords:
- Kidney Transplantation
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