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Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial
- Source :
- Trials, Vol 13, Iss 1, p 199 (2012), Trials
- Publication Year :
- 2012
- Publisher :
- BMC, 2012.
-
Abstract
- Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662
- Subjects :
- Graft Rejection
Oncology
medicine.medical_specialty
B-cells
Renal function
Medicine (miscellaneous)
Placebo
law.invention
Antibodies, Monoclonal, Murine-Derived
Study Protocol
Clinical Protocols
Double-Blind Method
Randomized controlled trial
law
Internal medicine
medicine
Cellular kidney allograft rejection
Humans
Immunologic Factors
Pharmacology (medical)
Kidney transplantation
B-Lymphocytes
lcsh:R5-920
business.industry
Standard treatment
medicine.disease
Kidney Transplantation
Surgery
Clinical trial
Research Design
Sample Size
Acute Disease
Monoclonal
Rituximab
business
lcsh:Medicine (General)
Glomerular Filtration Rate
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 13
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....f47060e425ce36c91661d9e57614149a