Impact of Rituximab (RTx) Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation

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.

Conditions

• Kidney Transplantation
• Rituximab (RTx)
• Living Donors
• Immunology
• Virus

Interventions

DRUG

Rituximab

375mg/m2 4 weeks before ABOi LD transplantation

PROCEDURE

living donor transplantation

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

PROCEDURE

deceased donor transplantation

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

Sponsors & Collaborators

• Heidelberg University

  collaborator OTHER

• German Cancer Research Center

  collaborator OTHER

• Astellas Pharma US, Inc.

  collaborator INDUSTRY

• Novartis

  collaborator INDUSTRY

• University of Giessen

  lead OTHER

Principal Investigators

• Rolf Weimer, Prof. Dr. · University of Giessen, Department of Internal Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2019-06-18

Completion

2019-06-18

Countries

• Germany

Study Locations