Trial record 2 of 2 for:    "Polyomavirus allograft nephropathy"

Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy

This study has been completed.
Sponsor:
Collaborators:
Heidelberg University
Hoffmann-La Roche
Astellas Pharma Inc
Novartis
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00160966
First received: September 8, 2005
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

The aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (PVN) including the impact of three immunosuppressive regimens.


Condition Intervention Phase
Polyomavirus Infections
Drug: CsA + MMF
Drug: Tacr + MMF
Drug: Tacr + MMF with conversion to Tacr + ERL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Characterize Risk Factors of Polyomavirus-related Transplant Nephropathy and the Impact of Three Immunosuppressive Regimens on Nephropathy Incidence

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • incidence of polyomavirus associated transplant nephropathy (PVN) [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: Yes ]
  • incidence of polyoma viremia [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: Yes ]
  • urine polyomavirus concentration within the first two years post-transplant [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients' and grafts' survival [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: Yes ]
  • incidence of acute rejections [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: Yes ]
  • transplant function 1 and 2 years post-transplant [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: No ]
  • comparison of urine cytology and polymerase chain reaction (PCR) quantitative data regarding diagnosis of PVN [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: No ]
  • predictive value of immune parameters prognostically relevant for acute or chronic rejection [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: No ]
  • side effects of immunosuppressive drugs [ Time Frame: 2 years posttransplant ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: September 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Immunosuppression with CsA/MMF
Drug: CsA + MMF
according to the Giessen protocol
Active Comparator: 2
Immunosuppression with Tacr/MMF
Drug: Tacr + MMF
according to Giessen protocol
Active Comparator: 3
Immunosuppression with Tacr/MMF with change from MMF to Everolimus after completion of posttransplant wound healing
Drug: Tacr + MMF with conversion to Tacr + ERL
according to Giessen protocol

Detailed Description:

Polyomavirus nephropathy (PVN) is an emerging cause of renal transplant loss. Until now the risk factors of PVN are poorly understood. Tacrolimus (Tacr) and mycophenolate mofetil (MMF) are thought to be associated with a higher risk of developing PVN. However, the way in which Tacr or MMF might enhance the susceptibility for PVN remains largely unknown. In this prospective study we will analyze whether differences in immune-reactivity patterns (Th1, Th2, B cell and monocyte responses, sCD30, immunoregulatory antibodies) of renal transplant patients induced by different immunosuppressive regimens (cyclosporine A [CsA]/MMF, Tacr/MMF, Tacr/MMF with conversion to Tacr/Everolimus [ERL]) or by cytokine promoter gene polymorphisms may account for the different risks of developing PVN.

Comparison(s): renal transplant recipients stratified according to their relative immunological risk (group 1: low risk (primary recipients without pre-immunization [PRA < 5%]); group 2: moderate risk (group 2a: primary recipients with low pre-immunization [PRA 6-20%]; group 2b: re-transplanted patients); group 3: very high risk (re-transplanted patients with a history of vascular rejection or recipients of a first graft with high pre-immunization [PRA > 20%]) randomized to be treated with one of three immunosuppressive regimens (CsA/MMF, Tacr/MMF, Tacr/MMF with subsequent conversion to Tacr/ERL).

  Eligibility

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

Inclusion Criteria:

  • Cadaver kidney and living donor kidney transplant recipients
  • Primary, secondary, and tertiary transplant recipients
  • Pre-immunized and not pre-immunized transplant recipients
  • Age > 18 years

Exclusion Criteria:

  • Contraindications against administration of one of the four study drugs
  • History of severe gastrointestinal morbidity
  • Age < 18 years
  • Pregnant or breast feeding women
  • Rejection of effective contraceptive methods with young women
  • Combined kidney and islet cell transplantation
  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: NCT00160966

Locations
Germany
Department of Internal Medicine, University of Giessen
Giessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Heidelberg University
Hoffmann-La Roche
Astellas Pharma Inc
Novartis
Investigators
Principal Investigator: Rolf Weimer, Prof., MD University Giessen, Internal Medicine
  More Information

Publications:

Responsible Party: Prof. Dr. Rolf Weimer, University of Giessen
ClinicalTrials.gov Identifier: NCT00160966     History of Changes
Other Study ID Numbers: NTx-PV-002
Study First Received: September 8, 2005
Last Updated: July 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
kidney transplantation
polyoma virus associated transplant nephropathy
tacrolimus
mycophenolate mofetil
everolimus
cyclosporin A
BK virus PCR
viruria screening
BK polyomavirus
immunosuppression

Additional relevant MeSH terms:
Kidney Diseases
Polyomavirus Infections
Urologic Diseases
DNA Virus Infections
Virus Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014