CompletedPhase 4

Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy

Germany108 participantsStarted 2004-09

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

incidence of polyomavirus associated transplant nephropathy (PVN)

Timeframe: 2 years posttransplant

incidence of polyoma viremia

Timeframe: 2 years posttransplant

urine polyomavirus concentration within the first two years post-transplant

Timeframe: 2 years posttransplant

Trial details

NCT IDNCT00160966

SponsorUniversity of Giessen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

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