Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138424
Status:
TERMINATED
Last Update Posted:
2013-03-08
First Post:
2005-08-26
Brief Title:
Cidofovir in Renal Transplant Recipients With BKVN
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Placebo-Controlled Dose-Escalation Study to Assess the Safety and Effect of Cidofovir in Renal Transplant Recipients With BK Virus Nephropathy
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at the safety tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy BKVN a viral condition that can cause patients to reject transplanted kidneys Up to 48 adult age 18 years and older kidney or pancreas transplant recipients with newly diagnosed BKVN will receive 1 of 3 cidofovir dose levels or placebo non medicated substance to identify the maximum tolerated dose Dosing will be administered intravenously by a tube running into a blood vessel In addition to the screening visit volunteers will actively participate for approximately 8-10 weeks with a single follow up phone call at 4 months Blood samples urine samples eye exams and physical exams are included in study procedures
Detailed Description:
The primary objectives of this randomized double-blind placebo-controlled dose-escalation study are to evaluate the safety and tolerability of 3 dose levels of cidofovir when administered to renal transplant recipients with BK virus nephropathy and to identify the maximum tolerated doses MTD among the 3 dose levels of cidofovir in renal transplant recipients with BK virus nephropathy The secondary study objectives are to evaluate the antiviral effect of cidofovir at each of 3 dose levels to evaluate the pharmacokinetics PK of cidofovir in renal transplant recipients with underlying renal impairment to evaluate the pharmacodynamics PD of cidofovir in this setting to evaluate allograft function at the completion of the study and to assess allograft rejection at the completion of the study Patients with BKVN virus nephropathy diagnosed by positive plasma polymerase chain reaction PCR or renal allograft biopsy will be randomized to receive study drug within 60 days of the date of the renal biopsy or plasma PCR assay that established the diagnosis of BKVN The study consists of three dose cohorts 025 mgkg 05 mgkg and 10 mgkg each cohort will consist of approximately 12 subjects randomized 21 to receive either cidofovir or placebo 09 normal saline to define the MTD among the three specified doses of cidofovir Once the MTD is established approximately 12 additional patients will be enrolled at that dose The MTD is defined as the dose in which no more than 2 of the 8 cidofovir treated subjects experience a dose limiting toxicity DLT The target enrollment is 48 subjects if all dose cohorts are fully enrolled A 25 over-enrollment may be tolerated to allow for continued enrollment of subjects in the lower dose cohort if data are under concomitant review by the Data and Safety Monitoring Board DSMB or to replace non-evaluable study participants Study participants who have been randomized and have received cidofovirplacebo in any cohort will be considered non-evaluable if they discontinue from the study or die for any reason except toxicities definitely related to study treatment including DLTs These subjects may be replaced There will be a 5-week drug administration period 4 doses followed by a 2 week end-of-study observation and evaluation period for each cohort At about 3 months after last dose of study infusion a member of the research staff will assess the study participant and counsel on pregnancy status via a phone call The study will be overseen by a DSMB who will review the data after each dose cohort is completed The primary endpoint of the study will assess the safety and tolerability of cidofovir in kidney transplant recipients this will be assessed by enumeration of adverse events AEs reported by the subjects andor investigator and changes observed in the physical examination including vital signs and laboratory evaluations during the drug administration and end-of-treatment observation and evaluation periods The severity and relationship of AEs to receipt of study drug will be determined because the primary endpoint is focusing on the safety The secondary endpoints are the effect of cidofovir on BK virus as determined by percentage of subjects who achieve an undetectable BK virus urine and plasma PCR between baseline and end of treatment rate of reduction in urine and plasma BK virus load by quantitative PCR between baseline and end of treatment and time to reduction in BK virus urine and plasma PCR the detailed PK of cidofovir will be evaluated in subjects at the MTD the PD of cidofovir will be assessed by quantitating the change in BK virus deoxyribonucleic aci
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASG 209 | None | None | None |