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A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 299 |
| Start date | 2006-05 |
| Completion | 2015-10 |
Conditions
- Cytomegalovirus Infections
Interventions
- Valganciclovir CMV Prophylaxis
- Valganciclovir (Pre-emptive CMV Therapy)
- Ganciclovir
Primary outcomes
- Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months — Up to 12 months
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). - Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease — Up to 12 months
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction. - Urine Proteomic Pattern at Month 12 — Up to 12 months
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration. - Percentage of Participants With Graft Loss at Month 84 — Up to 84 months
Countries
Austria, Germany