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

Sponsor
University of Giessen
Study ID
NCT01136395
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375mg/m2 4 weeks before ABOi LD transplantation
  • living donor transplantation — PROCEDURE
    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 transplantation — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
Jan 31, 2010
Status verified
Oct 2019
Primary completion
Jun 18, 2019
Completion
Jun 18, 2019

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Active Comparator: LD kidney transplantation, ABOc
    Living donor (LD) kidney transplantation, ABO compatible (ABOc); Immunosuppressive treatment: Tacr/MPS, Basiliximab induction
  • Active Comparator: DD kidney transplantation
    Deceased donor (DD) kidney transplantation, ABO compatible; Immunosuppressive treatment: Tacr/MPS, Basiliximab induction

Primary Outcome Measure

Impact of Rtx on immune parameters predictive of graft outcome including B cell responses [ Time Frame: 5 years posttransplant ]

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