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 - Rituximab in renal transplantatio

Phase 1

• Conditions: prophylaxis of acute rejection after renal transplantation

• Registration Number: EUCTR2007-001604-20-NL
• Lead Sponsor: Radboud University Nijmegen Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-27
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. All renal transplant recipients older than 18 years
2. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. Female patients at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication.
3. Signed, dated, and witnessed institutional review board (IRB) approved informed consent before screening and before any tests are performed that are specific to the protocol.

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

1. Recipients of a kidney from a living donor, who is HLA identical.
2. Patients with hemolytic uremic syndrome as original kidney disease.
3. Patients with focal segmental glomerulosclerosis that had recurred in a previous graft
4. Recipients with more than two previously failed grafts and/or PRA > 85%
5. Previous treatment with anti-CD20 antibodies.
6. Diabetes mellitus that is currently not treated with insulin
7. Total white blood cell count <3,000/mm3 or platelet count <75,000/mm3.
8. Active infection with hepatitis B, hepatitis C, or HIV.
9. History of tuberculosis.

Study & Design

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