Kidney Transplantation, Cytomegalovirus Infections Clinical Trial
Official title:
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
| Verified date | March 2014 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Months to 16 Years |
| Eligibility |
Inclusion Criteria: - Children, 4 months to 16 years of age - Patient has received a kidney transplant - At risk of developing cytomegalovirus disease - Adequate hematological and renal function - Able to tolerate oral medication - Negative pregnancy test for females of childbearing potential Exclusion Criteria: - Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past - Severe uncontrolled diarrhea (more than 5 watery stools per day) - Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)] - Patient requires use of any protocol prohibited concomitant medication - Previous participation in this clinical study |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Brazil, France, Germany, Mexico, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. |
52 weeks | No |
| Secondary | Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection. | 52 weeks | No |
| Secondary | Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever = 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis = 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction. | 52 weeks | No |
| Secondary | Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant | Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above. | 52 weeks | No |
| Secondary | Number of Participants With Biopsy Proven Rejection | Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997. | 52 Weeks | No |
| Secondary | Number of Participants With Graft Loss | Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation. | 52 Weeks | No |
| Secondary | Number of Participants With Death | 52 Weeks | No | |
| Secondary | Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) | All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir. | 52 Weeks | No |