Clinical Trial: Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomized Study to Characterize Risk Factors of Polyomavirus-related Transplant Nephropathy and the Impact of Three Immunosuppressive Regimens on Nephropathy Incidence

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

Detailed Summary:

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).


Sponsor: University of Giessen

Current Primary Outcome:

  • incidence of polyomavirus associated transplant nephropathy (PVN) [ Time Frame: 2 years posttransplant ]
  • incidence of polyoma viremia [ Time Frame: 2 years posttransplant ]
  • urine polyomavirus concentration within the first two years post-transplant [ Time Frame: 2 years posttransplant ]


Original Primary Outcome:

  • 1. incidence of polyoma virus associated transplant nephropathy (PVN)
  • 2. incidence of polyoma viremia
  • 3. urine polyoma virus concentration within the first two years post-transplant


Current Secondary Outcome:

  • patients' and grafts' survival [ Time Frame: 2 years posttransplant ]
  • incidence of acute rejections [ Time Frame: 2 years posttransplant ]
  • transplant function 1 and 2 years post-transplant [ Time Frame: 2 years posttransplant ]
  • comparison of urine cytology and polymerase chain reaction (PCR) quantitative data regarding diagnosis of PVN [ Time Frame: 2 years posttransplant ]
  • predictive value of immune parameters prognostically relevant for acute or chronic rejection [ Time Frame: 2 years posttransplant ]
  • side effects of immunosuppressive drugs [ Time Frame: 2 years posttransplant ]


Original Secondary Outcome:

  • - patients' and grafts' survival
  • - incidence of acute rejections
  • - transplant function 1 and 2 years post-transplant
  • - comparison of urine cytology and PCR quantitative data regarding diagnosis of PVN
  • - predictive value of immune parameters prognostically relevant for acute or chronic rejection
  • - side effects of immunosuppressive drugs


Information By: University of Giessen

Dates:
Date Received: September 8, 2005
Date Started: September 2004
Date Completion:
Last Updated: March 27, 2017
Last Verified: January 2017