A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
|ClinicalTrials.gov Identifier: NCT01376804|
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : April 28, 2014
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation, Cytomegalovirus Infections||Drug: valganciclovir [Valcyte]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients|
|Actual Study Start Date :||July 31, 2011|
|Actual Primary Completion Date :||May 31, 2013|
|Actual Study Completion Date :||May 31, 2013|
U.S. FDA Resources
Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Drug: valganciclovir [Valcyte]
Oral, daily for up to 200 days.
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs [ Time Frame: 52 weeks ]
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.
- Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator [ Time Frame: 52 weeks ]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.
- Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator [ Time Frame: 52 weeks ]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.
- Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant [ Time Frame: 52 weeks ]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.
- Number of Participants With Biopsy Proven Rejection [ Time Frame: 52 Weeks ]Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
- Number of Participants With Graft Loss [ Time Frame: 52 Weeks ]Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
- Number of Participants With Death [ Time Frame: 52 Weeks ]
- Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) [ Time Frame: 52 Weeks ]All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376804
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|Study Director:||Clinical Trials||Hoffmann-La Roche|