It should be proved that additional treatment with Rituximab in patients with histologic proof of an acute cellular rejection with CD20+ lymphocytes is superior to a solitary therapy with Steroidboli with regard to kidney function after one year. MedDRA version: 19.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: 1.male or female patients age = 18 at the time of the inclusion in the study 2.Kidney transplantation 25 ml/min/1,73 m² in the time period before the noticed rejection 6.Presence of a negative pregnancy test and consent to a highly effective contraceptiive method (i.e. failure rate less than 1% per year, which are implants, injectable contraceptives, combined oral contraceptives, intrauterine devices (only hormone spirals), sexual abstinence or vasectomy of the partner) in patients of child-bearing age. This does not apply to bilateral ovariectomy or sterilization of the patient and in patients that have exclusively female sex partners. 7.Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: Exclusion: 1.Known contraindications, resp. incompatibility for Rituximab resp. for the concomitant medication 2.Administration of Rituximab within the last 24 months before inclusion 3.Simultaneous participation in an other clinical study (observational studies and register excluded) 4.Breastfeeding women or pregnant women 5.Persons who fail to assess essence, meaning and significance of the clinical study and act along these lines (according to § 40 Abs. 4 und § 41 Abs. 2 und Abs. 3 AMG) 6.Existence of an active CMV-infection, existence of a HIV-infection, existence of a replicative hepatitis B or C, existence of other grave infections 7.Cardiac insufficiency in phase NYHA III-IV 8.High grade cardiac arrhythmias 9.Unstable coronary heart disease 10.Poorly adjusted diabetes mellitus at the time of the inclusion in the study. 11.State after splenectomy 12.Contra-indication referring to a renewed transplant biopsy (e.g. coagulopathy, anticoagulation) 13.Other exclusion criteria according to the estimate of the attending doctor (e.g. aggravation of the general health condition, occurrence of a malignant disease)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It should be proved that additional treatment with Rituximab in patients with histologic proof of an acute cellular rejection with CD20+ lymphocytes is superior to a solitary therapy with Steroidboli with regard to kidney function after one year.;Secondary Objective: n/a;Primary end point(s): Change in the GFR one year after rejection treatment in comparison to a baseline GFR for the state before the rejection detected by a principal investigator at the time of the randomization;Timepoint(s) of evaluation of this end point: one year after treatment | — |
Countries
Germany
Contacts
Public ContactStudienzentrum
Medizinische Hochschule Hannover, Studienzentrum für Nieren- und Hochdruckerkrankungen
Outcome results
None listed