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Cidofovir in Renal Transplant Recipients With BKVN

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00138424
First received: August 26, 2005
Last updated: February 28, 2013
Last verified: April 2011
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: BK Virus (Nephropathy)
Interventions: Drug: Cidofovir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort I - Cidofovir One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort I - Placebo One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort II - Cidofovir One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort II - Placebo One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)

Participant Flow:   Overall Study
    Cohort I - Cidofovir     Cohort I - Placebo     Cohort II - Cidofovir     Cohort II - Placebo  
STARTED     9     5     5     3  
COMPLETED     9     4     5     3  
NOT COMPLETED     0     1     0     0  
Physician Decision                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort I - Cidofovir One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort I - Placebo One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort II - Cidofovir One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Cohort II - Placebo One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Total Total of all reporting groups

Baseline Measures
    Cohort I - Cidofovir     Cohort I - Placebo     Cohort II - Cidofovir     Cohort II - Placebo     Total  
Number of Participants  
[units: participants]
  9     5     5     3     22  
Age, Customized  
[units: participants]
         
< 30 years old     1     2     0     0     3  
30-39 years old     0     0     0     0     0  
40-49 years old     1     2     0     1     4  
50-59 years old     3     1     2     0     6  
60-69 years old     4     0     2     1     7  
>= 70 years old     0     0     1     1     2  
Gender  
[units: participants]
         
Female     3     1     0     0     4  
Male     6     4     5     3     18  
Region of Enrollment  
[units: participants]
         
United States     9     5     5     3     22  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject   [ Time Frame: Baseline through day 49 ]

2.  Primary:   Number of Adverse Events by Grade of Event   [ Time Frame: Baseline through day 49. ]

3.  Primary:   Number of Related Adverse Events   [ Time Frame: Baseline through day 49. ]

4.  Primary:   Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)   [ Time Frame: Baseline through day 49. ]

5.  Primary:   Changes Observed in the Physical Examination: Blood Pressure (mm/hg)   [ Time Frame: Baseline through day 49. ]

6.  Primary:   Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)   [ Time Frame: Baseline through day 49. ]

7.  Primary:   Changes Observed in the Physical Examination: Heart Rate (Per Minute)   [ Time Frame: Baseline through day 49. ]

8.  Primary:   Number of Subjects Experiencing at Least One Laboratory Abnormality   [ Time Frame: Baseline through day 49 ]

9.  Secondary:   The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR   [ Time Frame: Day 35. ]

10.  Secondary:   Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit   [ Time Frame: Baseline, and each visit: day 7, 21, 35 and 49. ]

11.  Secondary:   Subjects Achieving 50% Reduction Viral Load in Plasma and Urine   [ Time Frame: Baseline through day 49. ]

12.  Secondary:   Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine   [ Time Frame: Baseline through day 49. ]

13.  Secondary:   Allograft Function at the Completion of the Study   [ Time Frame: Day 49. ]

14.  Secondary:   Allograft Rejection.   [ Time Frame: Day 49. ]

15.  Secondary:   The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline Through Day 35   [ Time Frame: Baseline through day 35 ]

16.  Secondary:   The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline and Day 35   [ Time Frame: Baseline through day 35 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study closed early due to failure to enroll in a timely manner.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Penelope Jester, BSN,MPH,CCRC
Organization: Collaborative Antiviral Study Group
phone: (205) 877-975-7280
e-mail: PJester@peds.uab.edu


No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00138424     History of Changes
Other Study ID Numbers: 04-047, CASG 209
Study First Received: August 26, 2005
Results First Received: June 14, 2012
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Federal Government