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Trial record 19 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

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

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ClinicalTrials.gov Identifier: NCT01136395
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
Heidelberg University
German Cancer Research Center
Astellas Pharma US, Inc.
Novartis
Information provided by (Responsible Party):
Prof. Dr. Rolf Weimer, University of Giessen

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Rituximab (RTx) Living Donors Immunology Virus Drug: Rituximab Procedure: living donor transplantation Procedure: deceased donor transplantation Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 2010
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
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 ABOi LD transplantation
Other Names:
  • Blood group incompatible (ABOi) living donor (LD) renal transplantation
  • Anti-CD20 (cluster of differentiation 20) Monoclonal Antibody (MoAb)

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: Blood group compatible (ABOc) LD NTx

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: Blood group compatible (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 virus (BKV), JC virus (JCV)), respectively
Other Name: Deceased donor (DD) renal transplantation




Primary Outcome Measures :
  1. Impact of Rtx on immune parameters predictive of graft outcome including B cell responses [ Time Frame: 5 years posttransplant ]
    immune parameters of graft outcome: see "detailed description"

  2. Impact of living donation on immune parameters predictive of graft outcome including B cell responses [ Time Frame: 5 years posttransplant ]
    parameters of graft outcome: see "detailed description"

  3. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: EBV PCR (in blood)

  4. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: CMV PCR (in blood)

  5. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: BKV PCR (in blood)

  6. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: BKV PCR (in urine)

  7. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: JCV PCR (in blood)

  8. Impact of Rtx on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: JCV PCR (in urine)

  9. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: EBV PCR (in blood)

  10. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: CMV PCR (in blood)

  11. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: BKV PCR (in blood)

  12. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: BKV PCR (in urine)

  13. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: JCV PCR (in blood)

  14. Impact of living donation on virus replication [ Time Frame: 5 years posttransplant ]
    outcome measure description: JCV PCR (in urine)


Secondary Outcome Measures :
  1. Patient survival [ Time Frame: 5 years posttransplant ]
    patient survival 5 years posttransplant will be analyzed

  2. Graft survival [ Time Frame: 5 years posttransplant ]
    Graft survival 5 years posttransplant will be analyzed

  3. Graft function and proteinuria [ Time Frame: 5 years posttransplant ]
    5-year graft function will be analyzed by serum creatinine and measured creatinine clearance, proteinuria by proteinuria within a 24h urine collection period

  4. Graft function [ Time Frame: 5 years posttransplant ]
    5-year graft function will be analyzed by serum creatinine and measured creatinine clearance, proteinuria by proteinuria within a 24h urine collection period

  5. Graft function [ Time Frame: 5 years posttransplant ]
    5-year graft function will be analyzed by measured creatinine clearance

  6. Proteinuria [ Time Frame: 5 years posttransplant ]
    5-year proteinuria will be analyzed urine collected 24 hours

  7. Incidence of acute rejection [ Time Frame: 1 year posttransplant ]
    incidence of biopsy proven acute rejection within 1 year posttransplant will be analyzed

  8. Incidence of acute rejection [ Time Frame: 2 years posttransplant ]
    incidence of biopsy proven acute rejection within 2 years posttransplant will be analyzed

  9. Incidence of acute rejection [ Time Frame: 5 years posttransplant ]
    incidence of biopsy proven acute rejection within 5 years posttransplant will be analyzed

  10. Incidence of chronic allograft dysfunction [ Time Frame: 5 years posttransplant ]
    Chronic allograft dysfunction (progressive decline of graft function) will be analyzed at 5 years posttransplant.

  11. Incidence of severe infectious disease [ Time Frame: 5 years posttransplant ]
    severe infectious disease as defined by need for in-hospital treatment

  12. Incidence of malignancy [ Time Frame: 5 years posttransplant ]
    all types of malignancies within 5 years posttransplant will be evaluated

  13. Incidence of side effects associated with Rtx [ Time Frame: 5 years posttransplant ]
    all side effects of Rtx treatment which have been described in literature, will be listed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136395


Locations
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Germany
Department of Internal Medicine, University of Giessen
Giessen, Germany, D-35392
Sponsors and Collaborators
University of Giessen
Heidelberg University
German Cancer Research Center
Astellas Pharma US, Inc.
Novartis
Investigators
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Principal Investigator: Rolf Weimer, Prof. Dr. University of Giessen, Department of Internal Medicine

Publications:

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Responsible Party: Prof. Dr. Rolf Weimer, head of renal transplant program, University of Giessen, University of Giessen
ClinicalTrials.gov Identifier: NCT01136395     History of Changes
Other Study ID Numbers: NTx-RTx-LD-001
2009-012198-36 ( EudraCT Number )
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant data are available to the members of the study group who treat the patients in the Department of Internal Medicine, University Clinic of Giessen (i.e. all participants of the study group working in the Department of Internal Medicine)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available up to 1year post study completion
Access Criteria: seen above
Keywords provided by Prof. Dr. Rolf Weimer, University of Giessen:
Kidney Transplantation
Rituximab
Living Donor
ABO Incompatible (ABOi) Transplantation
Immunology
Cytomegalovirus (CMV)
Epstein Barr virus (EBV)
Polyomavirus
Additional relevant MeSH terms:
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Virus Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents