Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Collaborators: Astellas Pharma Inc; Heidelberg University; Hoffmann-La Roche; Novartis
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Immunosuppressive Agents; Mycophenolic Acid; Tacrolimus

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