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.
Schiffer L, Schiffer M, et al.Trials 2012; 13(1): 199.
Aims
This protocol compares the efficacy of rituximab against standard treatment with steroid-boli, in improving one year kidney allograft function in patients with T-cell mediated tubulointerstitial rejection and significant β-cell infiltrates.
Interventions
The study protocol outlines two groups that received either a standard treatment which includes two steroid boli plus placebo (500ml NaCl0, 9%) or standard treatment steroid boli and a single dose of rituximab (375 mg/m²). Both groups will receive additional medication to prevent side effects.
Participants
180 patients aged ≥18 years with an acute T-cell mediated tubulointerstitial rejection or borderline rejection with simultaneous increase of creatinine and β-cell infiltrates.
Outcomes
The primary outcome is the change of the glomerular filtration rate (GFR) one year after intervention, compared to the baseline GFR before the rejection episode. The secondary outcomes include the progression of interstitial fibrosis and tubular atrophy between the allograft biopsy that led to the study enrolment and a scheduled protocol biopsy one year after intervention. Safety and side effects of rituximab in kidney transplanted patients are also included as secondary outcomes.
Follow-up
1 year.
CET Conclusions
This is an interesting proposal for a double blind randomised placebo controlled multicentre study which may define the role of the B cell in T cell mediated rejection in renal transplant recipients. The protocol is methodologically sound.
Quality notes
As this paper is a protocol, it has not been quality assessed.
Trial registration
ClinicalTrials.gov – NCT01117662