"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH) one year [clinicaltrials_resource:5ebc4d71d0e458bec40ab4c1f8a1c275]
Patients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH) one year [clinicaltrials_resource:5ebc4d71d0e458bec40ab4c1f8a1c275]
Patients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab.
Bio2RDF identifier
5ebc4d71d0e458bec40ab4c1f8a1c275
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:5ebc4d71d0e458bec40ab4c1f8a1c275
measure [clinicaltrials_vocabulary:measure]
"Treatment failure" grouping a ...... creatinine reached at the RAH)
time frame [clinicaltrials_vocabulary:time-frame]
description
Patients randomized into the a ...... onal treatment with rituximab.
identifier
clinicaltrials_resource:5ebc4d71d0e458bec40ab4c1f8a1c275
title
"Treatment failure" grouping a ...... e reached at the RAH) one year
@en
type
label
"Treatment failure" grouping a ...... c4d71d0e458bec40ab4c1f8a1c275]
@en