CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01136395
NCT01136395Phase 2Completed
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Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation - a Prospective Pilot Study

University of Giessen·interventional·Posted Jun 3, 2010·Updated Oct 8, 2019

In Brief

A Phase 2 clinical trial evaluating Rituximab, living donor transplantation, and 1 other intervention for Kidney Transplantation and 4 related conditions. Completed, enrolled 85 participants across 1 site.

Detailed Summary

This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK virus (BKV), JC virus (JCV), cytomegalovirus (CMV), Epstein Barr virus (EBV)) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation, Rituximab (RTx), Living Donors, Immunology, Virus
CountriesGermany
CollaboratorsHeidelberg University, German Cancer Research Center, Astellas Pharma US, Inc., Novartis

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 18, 2019
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 16.1 years ago

Interventions

Rituximabdrug

375mg/m2 4 weeks before ABOi LD transplantation

living donor transplantationprocedure

living donor transplantation (ABO compatible) to be compared with deceased donor transplantation (ABO compatible) in its impact on immunological parameters of graft outcome and on viral replication (CMV, EBV, BK/JC), respectively

deceased donor transplantationprocedure

deceased donor transplantation (ABO compatible) to be compared with living donor transplantation (ABO compatible) in its impact on immunological parameters of graft outcome and on viral replication (CMV, EBV, BK virus (BKV), JC virus (JCV)), respectively