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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00565331
Other study ID # RRT06
Secondary ID UMC Radboud RI00
Status Completed
Phase Phase 2/Phase 3
First received November 28, 2007
Last updated November 9, 2015
Start date December 2007
Est. completion date June 2015

Study information

Verified date November 2015
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Our standard immunosuppressive treatment after renal transplantation is a combination of tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute rejection within the first six months after transplantation has dropped to about 20%. The main challenge at present remains to improve long-term outcome by preventing chronic allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further decrease in the incidence of acute rejection can improve the long-term graft survival. Current strategies to prevent rejection are mainly directed at alloreactive T cells. Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has increased. In addition, anti-B cell therapy was shown to be effective in diseases that were considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has been suggested that anti-B cell antibodies may impair the antigen presenting function of B cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.

Study design: Double-blind, placebo controlled intervention study. One group receives a single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the other group receives a placebo infusion.

Primary Objective:

To determine the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

Secondary Outcomes:

- Renal function as estimated by the endogenous creatinine clearance at 6 months

- Occurrence of chronic allograft nephropathy at 6 months

- Cumulative incidence of infections and malignancies at 6 months

- Medical costs during the first 6 months after transplantation

- Patient and graft survival


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date June 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
Placebo
saline solution

Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Astellas Pharma GmbH, Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Pescovitz MD. Rituximab, an anti-cd20 monoclonal antibody: history and mechanism of action. Am J Transplant. 2006 May;6(5 Pt 1):859-66. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of biopsy-confirmed acute rejection First six months after transplantation No
Secondary Renal function as estimated by the endogenous creatinine clearance 6 months after transplantation No
Secondary Occurrence of chronic allograft nephropathy First 6 months after transplantation No
Secondary Cumulative incidence of infections and malignancies First 6 months after transplantation Yes
Secondary Patient and graft survival First six months after transplantation Yes
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