Rituximab for Prevention of Rejection After Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Rituximab

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

saline solution

Interventions

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Rituximab

single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation

Intervention Type DRUG

Placebo

saline solution

Intervention Type DRUG

Other Intervention Names

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Mabthera, Rituxan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No