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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by University of Giessen
Sponsor:
Collaborators:
University Hospital Freiburg
Heidelberg University
German Cancer Research Center
Astellas Pharma US, Inc.
Novartis
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01136395
First received: June 2, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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, JC, CMV, EBV) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.


Condition Intervention Phase
Kidney Transplantation
Rituximab
Living Donors
Immunology
Virus
Drug: Rituximab
Procedure: living donor transplantation
Procedure: deceased donor transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation - a Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Impact of Rtx on immune parameters predictive of graft outcome including B cell responses [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: No ]
    immune parameters of graft outcome: see "detailed description"

  • Impact of living donation on immune parameters predictive of graft outcome including B cell responses [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: No ]
    parameters of graft outcome: see "detailed description"

  • Impact of Rtx on virus replication (EBV, CMV, BK/JC) [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Impact of living donation on virus replication (EBV, CMV, BK/JC) [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient and graft survival [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Graft function and proteinuria [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Incidence of acute rejection [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Incidence of chronic allograft dysfunction [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Incidence of severe infectious disease [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
    severe infectious disease as defined by need for in-hospital treatment

  • Incidence of malignancy [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]
  • Incidence of side effects associated with Rtx [ Time Frame: 5 years posttransplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LD kidney transplantation, ABOi
Living donor (LD) kidney transplantation, ABO incompatible (ABOi); Immunosuppressive treatment: Tacrolimus (Tacr)/ Mycophenolate sodium (MPS), Basiliximab induction, Rtx induction
Drug: Rituximab
375mg/m2 4 weeks before ABO incompatible LD transplantation
Other Names:
  • ABOi LD NTx
  • Anti-CD20 MoAb
Active Comparator: LD kidney transplantation, ABOc
Living donor (LD) kidney transplantation, ABO compatible (ABOc); Immunosuppressive treatment: Tacr/MPS, Basiliximab induction
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
Other Name: ABOc LD NTx
Active Comparator: DD kidney transplantation
Deceased donor (DD) kidney transplantation, ABO compatible; Immunosuppressive treatment: Tacr/MPS, Basiliximab induction
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/JC), respectively
Other Name: DD NTx

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • De-novo kidney transplantation
  • Deceased donors (blood group compatible) and living donors (blood group incompatible / blood group compatible)
  • First, second and third renal transplants
  • Immunized and non-immunized graft recipients
  • Age of recipients 18 years or older
  • Negative pregnancy test before transplantation

Exclusion Criteria:

  • Contra-indications to use Tacr and MPS, respectively
  • Contra-indications to use Rtx in the group of ABOi LD transplants
  • Chronic hepatitis B, C or HIV infection
  • Recurrent infectious disease
  • Previous hepatitis B, if no prophylactic antiviral therapy is used
  • Previous tuberculosis
  • Hemoglobin<8,5g/dl, thrombocytes<80.000/ul or leucocytes<3000/ul
  • Previous vaccination with a living vaccine <4 weeks pretransplant
  • Significant enterogastric disease such as diverticulitis (contra-indicates MPS treatment)
  • Children and adolescents (age less than 18 years)
  • Pregnancy and breast-feeding women
  • Refusal of an effective contraception in women capable of bearing children
  • Combined transplantations such as simultaneous islet/kidney transplants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136395

Contacts
Contact: Fabrice Renner, MD ++49-641-99-42112 fabrice.renner@innere.med.uni-giessen.de
Contact: Rolf Weimer, Prof. Dr. ++49-641-99-42398 rolf.weimer@innere.med.uni-giessen.de

Locations
Germany
Departments of Surgery and Internal Medicine, University of Freiburg Not yet recruiting
Freiburg, Germany, D-79106
Contact: Przemyslaw Pisarski, Dr.    ++49-761-270-2840    przemyslaw.pisarski@uniklinik-freiburg.de   
Contact: Karl-Georg Fischer, PD Dr.    ++49-761-270-3424    karl-georg.fischer@uniklinik-freiburg.de   
Principal Investigator: Przemyslaw Pisarski, Dr.         
Sub-Investigator: karl-georg fischer, PD Dr.         
Department of Internal Medicine, University of Giessen Recruiting
Giessen, Germany, D-35392
Principal Investigator: Rolf Weimer, Prof. Dr.         
Sub-Investigator: Fabrice Renner, Dr.         
Sponsors and Collaborators
University of Giessen
University Hospital Freiburg
Heidelberg University
German Cancer Research Center
Astellas Pharma US, Inc.
Novartis
Investigators
Principal Investigator: Rolf Weimer, Prof. Dr. University of Giessen, Department of Internal Medicine
  More Information

Publications:

Responsible Party: Prof. Dr. Rolf Weimer, University of Giessen
ClinicalTrials.gov Identifier: NCT01136395     History of Changes
Other Study ID Numbers: NTx-RTx-LD-001, 2009-012198-36
Study First Received: June 2, 2010
Last Updated: June 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Kidney Transplantation
Rituximab
Living Donor
ABO Incompatible Transplantation
Immunology
CMV
EBV
Polyomavirus

Additional relevant MeSH terms:
Virus Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014