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Valganciclovir CMV Prophylaxis · 1 trial · 1 indication
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
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.
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.
| Arm | Type | Description |
|---|---|---|
| Valganciclovir Cytomegalovirus (CMV) Prophylaxis | EXPERIMENTAL | - |
| Pre-emptive CMV Therapy | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Valganciclovir CMV Prophylaxis | DRUG | 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation. |
| Valganciclovir (Pre-emptive CMV Therapy) | DRUG | If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir. |
| Ganciclovir | DRUG | If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir. |
Inclusion Criteria: * primary or secondary renal allograft within preceding 14 days; * IgG seropositive for CMV; * receiving immunosuppressive therapy. Exclusion Criteria: * active CMV infection; * current/history of malignancy; * acute steroid resistant rejection episode since transplantation.
Valganciclovir CMV Prophylaxis is used for the prevention of cytomegalovirus (CMV) infections. It is being studied in patients after renal transplantation to prevent CMV disease. The drug is an investigational small molecule in Phase 3 clinical development for this indication.
Valganciclovir CMV Prophylaxis is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug for the prevention of cytomegalovirus infections in patients who have undergone renal transplantation.
Valganciclovir CMV Prophylaxis is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for the prevention of cytomegalovirus infections after renal transplantation.
Valganciclovir CMV Prophylaxis has one completed Phase 3 clinical trial, NCT00372229, titled 'A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation.' This randomized, active-controlled trial enrolled 299 participants in Austria and Germany to evaluate the drug for cytomegalovirus infections.
Valganciclovir CMV Prophylaxis is also known as Valcyte, as indicated by the clinical trial title. The Phase 3 study NCT00372229 refers to the drug as Valcyte (valganciclovir) for CMV prophylaxis after renal transplantation. Both names refer to the same investigational drug.