Trial Outcomes & Findings for Cidofovir in Renal Transplant Recipients With BKVN (NCT NCT00138424)

Last Updated: 2013-03-08

Results Overview

The measure is the number of adverse events (ie: events that are change from baseline)experienced by subjects. The median or average number of events and the range of events across all subjects is reported.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Baseline through day 49

Results posted on

2013-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	9	5	5	3
Overall Study COMPLETED	9	4	5	3
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Physician Decision	0	1	0	0

Baseline Characteristics

Cidofovir in Renal Transplant Recipients With BKVN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Total n=22 Participants Total of all reporting groups
Age, Customized < 30 years old	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Age, Customized 30-39 years old	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age, Customized 40-49 years old	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Age, Customized 50-59 years old	3 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	6 participants n=21 Participants
Age, Customized 60-69 years old	4 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants
Age, Customized >= 70 years old	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment United States	9 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	3 participants n=4 Participants	22 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline through day 49

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject	3 Event Interval 2.0 to 15.0	4 Event Interval 1.0 to 4.0	3 Event Interval 3.0 to 5.0	7 Event Interval 2.0 to 11.0

PRIMARY outcome

Timeframe: Baseline through day 49.

Adverse events are reported as grades: Toxicity Grade I: a mild event (an event that requires minimal or no treatment and does not interfere with the subject's daily activities. Toxicity Grade II: a moderate event (an event that results in a low level of inconvenience or concern with the therapeutic measures and may cause some interference with functioning. Toxicity Grade III: a severe event (an event that interrupts a subject's usual daily activity and may require systemic drug therapy or other treatment and may be incapacitating. Toxicity Grade IV: Life threatening (any adverse drug experience that places the patient or subject at immediate risk of death from the reaction as it occurred)

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Number of Adverse Events by Grade of Event Grade 1	26 Events	4 Events	10 Events	2 Events
Number of Adverse Events by Grade of Event Grade 2	2 Events	6 Events	1 Events	2 Events
Number of Adverse Events by Grade of Event Grad3 3	0 Events	2 Events	0 Events	0 Events
Number of Adverse Events by Grade of Event Grade 4	0 Events	0 Events	0 Events	0 Events

PRIMARY outcome

Timeframe: Baseline through day 49.

Population: Number of Related Events

The investigator's assessment of an AE's relationship to study drug is part of the documentation process. All adverse events had their relationship to study product assessed using the following terms: associated (related)or not associated (not related). To help assess, the following guidelines were used. * Associated - There was a known temporal relationship and/or, if re-challenge was done, the event abates with de-challenge and reappears with re-challenge and/or the event was known to occur in association study product or with a product in a similar class of study products * Not Associated -the AE was completely independent of study product administration; and/or evidence existed that the event was definitely related to another etiology.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Number of Related Adverse Events	6 Events	6 Events	1 Events	1 Events

PRIMARY outcome

Timeframe: Baseline through day 49.

Population: subjects whose respiratory rate was measured at baseline visit and at day 49 visit.

Respiratory rate is the number of breaths per minute.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)	0 Change in Breaths per Minute Interval -4.0 to 6.0	0 Change in Breaths per Minute Interval -4.0 to 2.0	0 Change in Breaths per Minute Interval -4.0 to 2.0	-2 Change in Breaths per Minute Interval -4.0 to 0.0

PRIMARY outcome

Timeframe: Baseline through day 49.

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. "Blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, blood pressure varies between a maximum (systolic) and a minimum (diastolic) pressure. The measure is the difference between the baseline systolic and baseline diastolic value with the day 49 systolic and day 49 diastolic value.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Changes Observed in the Physical Examination: Blood Pressure (mm/hg) Systolic Blood Pressure	10 mm Hg Interval -31.0 to 38.0	-4 mm Hg Interval -8.0 to 51.0	-3 mm Hg Interval -17.0 to 39.0	3 mm Hg Interval -46.0 to 6.0
Changes Observed in the Physical Examination: Blood Pressure (mm/hg) Diastolic Blood Pressure	1 mm Hg Interval -14.0 to 1.0	6 mm Hg Interval 2.0 to 14.0	10 mm Hg Interval -8.0 to 22.0	-4 mm Hg Interval -25.0 to 2.0

PRIMARY outcome

Timeframe: Baseline through day 49.

Population: Subject's last visit minus baseline visit

The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)	0.18 Temperature (F) Interval -1.82 to 0.18	0.72 Temperature (F) Interval -0.54 to 60.46	-0.42 Temperature (F) Interval -1.0 to 0.5	0.3 Temperature (F) Interval -0.7 to 4.3

PRIMARY outcome

Timeframe: Baseline through day 49.

Population: Subject's whose heart rate was measured at baseline and day 49 visit

The heart rate is the number of heart beats per minute. The outcome measure is the change from baseline heart rate to day 49 heart rate.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Changes Observed in the Physical Examination: Heart Rate (Per Minute)	-3 Change in Beats per Minute Interval -22.0 to 1.0	3 Change in Beats per Minute Interval -17.0 to 13.0	4 Change in Beats per Minute Interval -14.0 to 21.0	-4 Change in Beats per Minute Interval -7.0 to 48.0

PRIMARY outcome

Timeframe: Baseline through day 49

The following lab values assessed during the 49 days of subject involvement were the following: hemoglobin, hematocrit, platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), serum creatinine, calcium, phosphorous, serum albumin, glucose, uric acid, magnesium, total protein, total bilirubin, alanine aminotransferase (ALT), asparate aminotransferase (AST) and alkaline phosphate. The outcome measure is the number of subjects experiencing at least 1 grade 1 (mild) or higher event.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Number of Subjects Experiencing at Least One Laboratory Abnormality WBC	3 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Hemoglobin	6 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Hematocrit	6 Participants	5 Participants	2 Participants	3 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Platelets	3 Participants	2 Participants	3 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Sodium	3 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Potassium	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Chloride	4 Participants	5 Participants	3 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Bicarbonate	5 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality BUN	9 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Serum Creatinine	8 Participants	5 Participants	4 Participants	3 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Calcium	5 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Phosphorous	5 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Serum Albumin	4 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Glucose	7 Participants	2 Participants	3 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Uric Acid	1 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Magnesium	5 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Total Protein	4 Participants	3 Participants	0 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Total Bilirubin	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality ALT (SGPT)	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality AST (SGOT)	2 Participants	3 Participants	0 Participants	1 Participants
Number of Subjects Experiencing at Least One Laboratory Abnormality Alkaline Phosphate	4 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 35.

Population: Percentage of subjects

The outcome measure is the percent of subjects that achieved non-detectable BK virus in the urine and plasma polymerase chain reaction (PCR) at day 35 after staring study drug. Undetectable is a PCR viral load of less than 200.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR Plasma	0 percentage of subjects	20 percentage of subjects	0 percentage of subjects	0 percentage of subjects
The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR Urine	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, and each visit: day 7, 21, 35 and 49.

The percent change in viral load from baseline to day 7, day 21 and day 49 as measured in the urine and measured in the blood. A drop is identified by use of '-', an increase in viral load has no sign in front of the number.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 7 Plasma	21.6 Percent Change Interval -195.2 to 60.7	61.9 Percent Change Interval -17.3 to 99.8	21.2 Percent Change Interval 2.5 to 70.1	7.9 Percent Change Interval -268.8 to 36.1
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 7 Urine	9.1 Percent Change Interval -149.3 to 87.9	19.1 Percent Change Interval -55299.7 to 80.0	-3.1 Percent Change Interval -319.5 to 26.5	1.6 Percent Change Interval -579.6 to 26.4
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 21 Plasma	35.9 Percent Change Interval -387.5 to 88.1	75.6 Percent Change Interval -75.6 to 99.8	58.4 Percent Change Interval -6.3 to 89.4	53.9 Percent Change Interval -174.9 to 71.9
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 21 Urine	18.3 Percent Change Interval -3.7 to 99.6	26.2 Percent Change Interval -108553.1 to 94.5	8.1 Percent Change Interval -102.1 to 60.1	11.1 Percent Change Interval -63.6 to 97.4
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 35 Plasma	44.8 Percent Change Interval -295.2 to 93.3	91.3 Percent Change Interval 2.7 to 99.8	76.2 Percent Change Interval 35.9 to 93.2	83.3 Percent Change Interval -402.0 to 93.8
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 35 Urine	27.6 Percent Change Interval -32.1 to 99.7	29.9 Percent Change Interval -88968.7 to 97.8	25.5 Percent Change Interval 3.2 to 76.8	8.3 Percent Change Interval -7.1 to 92.4
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 49 Plasma	56.5 Percent Change Interval -22.8 to 96.5	95.0 Percent Change Interval -72.4 to 99.6	76.7 Percent Change Interval 15.8 to 91.3	65.1 Percent Change Interval -1094.4 to 75.5
Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit Day 49 Urine	42.4 Percent Change Interval -142.3 to 99.8	86.1 Percent Change Interval -65494.3 to 95.8	-0.7 Percent Change Interval -31.1 to 86.5	12.9 Percent Change Interval -51.5 to 86.4

SECONDARY outcome

Timeframe: Baseline through day 49.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Subjects Achieving 50% Reduction Viral Load in Plasma and Urine Number of Subjects at 50% Reduction in Plasma	6 Participants	4 Participants	5 Participants	2 Participants
Subjects Achieving 50% Reduction Viral Load in Plasma and Urine Number of Subject at 50% Reduction in Urine	4 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline through day 49.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine Urine	14.5 Days Interval 7.0 to 21.0	35 Days Interval 7.0 to 49.0	29 Days Interval 22.0 to 36.0	20 Days Interval 20.0 to 20.0
Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine Plasma	21.5 Days Interval 7.0 to 51.0	7.5 Days Interval 7.0 to 21.0	22 Days Interval 7.0 to 50.0	20.5 Days Interval 20.0 to 21.0

SECONDARY outcome

Timeframe: Day 49.

Population: subjects that had GFR at each visit last visit

Glomerular filtration rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute. The normal health GFR is about 90 - 120 mL/min/1.73 m2. Older people will have lower normal GFR levels, because GFR decreases with age. Abnormal Results are expected to be below 60 mL/min/1.73 m2 for 3 or more months are a sign of chronic kidney disease. A GFR result below 15 mL/min/1.73 m2 may be a sign of kidney failure.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Allograft Function at the Completion of the Study	42.7 mL/min/1.73 m2 Interval 26.5 to 72.9	40.3 mL/min/1.73 m2 Interval 30.0 to 57.8	45.1 mL/min/1.73 m2 Interval 36.1 to 90.5	63.2 mL/min/1.73 m2 Interval 22.6 to 84.7

SECONDARY outcome

Timeframe: Day 49.

Population: Number of rejections

Allograft rejection is the number of subjects that rejected their kidney by the end of the study.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 Participants One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Allograft Rejection.	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through day 35

PK parameter change from baseline to day 35 for Cmax.

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants 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)
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	190.4 ng/mL Interval -212.2 to 5173.9	-233.9 ng/mL Interval -338.3 to 242.9	—	—

SECONDARY outcome

Timeframe: Baseline through day 35

PK parameter change from baseline to day 35 for AUC4 and AUC12

Outcome measures

Outcome measures
Measure	Cohort I - Cidofovir n=9 Participants One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 Participants 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)
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 AUC12	0.3 hr*mg/L Interval -0.7 to 4.2	0.1 hr*mg/L Interval -0.5 to 1.5	—	—
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 AUC4	0.5 hr*mg/L Interval -0.5 to 3.9	-0.1 hr*mg/L Interval -0.5 to 0.8	—	—

Adverse Events

Cohort I - Cidofovir

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort I - Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort II - Cidofovir

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort II - Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort I - Cidofovir n=9 participants at risk One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort I - Placebo n=5 participants at risk One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Cidofovir n=5 participants at risk One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)	Cohort II - Placebo n=3 participants at risk One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
Infections and infestations Cellulitis	0.00% 0/9 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	20.0% 1/5 • Number of events 1 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	0.00% 0/5 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	0.00% 0/3 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..
Immune system disorders Transplant Rejection	0.00% 0/9 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	0.00% 0/5 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	0.00% 0/5 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..	33.3% 1/3 • Number of events 1 • SAEs were reported within one business day of awareness of the event by completing Serious Adverse Event Report. Events were reported from start of study drug use to end of study..

Other adverse events

Additional Information

Penelope Jester, BSN,MPH,CCRC

Collaborative Antiviral Study Group

Phone: (205) 877-975-7280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60