Trial · NCT00138424
Cidofovir in Renal Transplant Recipients With BKVN
NCT00138424, Phase 1, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2013-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cidofovir in Renal Transplant Recipients With BKVN. Trials, record NCT00138424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00138424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cidofovir in Renal Transplant Recipients With BKVN
- NCT number
- NCT00138424
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- BK Virus (Nephropathy)
- Interventions
- Cidofovir, Placebo
- First posted
- 2005-08-30
- Last updated
- 2013-03-08
- Results first posted
- 2013-01-07
- Limitations and caveats
- The study closed early due to failure to enroll in a timely manner.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Baseline through day 49 | 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. |
| Primary | Number of Adverse Events by Grade of Event | 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) |
| Primary | Number of Related Adverse Events | Baseline through day 49. | 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. |
| Primary | Changes Observed in the Physical Examination : Respiratory Rate (Per Minute) | Baseline through day 49. | Respiratory rate is the number of breaths per minute. |
| Primary | Changes Observed in the Physical Examination: Blood Pressure (mm/hg) | 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. |
| Primary | Changes Observed in the Physical Examination: Body Temperature (Fahrenheit) | Baseline through day 49. | The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature. |
| Primary | Changes Observed in the Physical Examination: Heart Rate (Per Minute) | Baseline through day 49. | 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. |
| Primary | Number of Subjects Experiencing at Least One Laboratory Abnormality | 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. |
| Secondary | The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR | Day 35. | 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. |
| Secondary | Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Baseline through day 49 | Event | MEDIAN | |
| SECONDARY | The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR | Day 35. | Percentage of subjects | percentage of subjects | NUMBER |
| SECONDARY | Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit | Baseline, and each visit: day 7, 21, 35 and 49. | Percent Change | MEDIAN | |
| SECONDARY | Subjects Achieving 50% Reduction Viral Load in Plasma and Urine | Baseline through day 49. | Participants | NUMBER | |
| SECONDARY | Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine | Baseline through day 49. | Days | MEDIAN | |
| PRIMARY | Number of Adverse Events by Grade of Event | Baseline through day 49. | Events | NUMBER | |
| PRIMARY | Number of Related Adverse Events | Baseline through day 49. | Number of Related Events | Events | NUMBER |
| PRIMARY | Changes Observed in the Physical Examination : Respiratory Rate (Per Minute) | Baseline through day 49. | subjects whose respiratory rate was measured at baseline visit and at day 49 visit. | Change in Breaths per Minute | MEDIAN |
| PRIMARY | Changes Observed in the Physical Examination: Blood Pressure (mm/hg) | Baseline through day 49. | mm Hg | MEDIAN | |
| SECONDARY | Allograft Function at the Completion of the Study | Day 49. | subjects that had GFR at each visit last visit | mL/min/1.73 m2 | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group198
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Cohort I - Cidofovir | 3 | Full Range 2 to 15 | Event | |
| Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Cohort I - Placebo | 4 | Full Range 1 to 4 | Event | |
| Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Cohort II - Cidofovir | 3 | Full Range 3 to 5 | Event | |
| Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject | Cohort II - Placebo | 7 | Full Range 2 to 11 | Event | |
| The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR | Cohort I - Cidofovir | Plasma | 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 | Cohort I - Placebo | Plasma | 20 | 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 | Cohort II - Cidofovir | Plasma | 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 | Cohort II - Placebo | Plasma | 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 | Cohort I - Cidofovir | Urine | 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 | Cohort I - Placebo | Urine | 0 | percentage of subjects |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I - Cidofovir | 9 | |
| Overall Study | STARTED | Cohort I - Placebo | 5 | |
| Overall Study | STARTED | Cohort II - Cidofovir | 5 | |
| Overall Study | STARTED | Cohort II - Placebo | 3 | |
| Overall Study | COMPLETED | Cohort I - Cidofovir | 9 | |
| Overall Study | COMPLETED | Cohort I - Placebo | 4 | |
| Overall Study | COMPLETED | Cohort II - Cidofovir | 5 | |
| Overall Study | COMPLETED | Cohort II - Placebo | 3 | |
| Overall Study | NOT COMPLETED | Cohort I - Cidofovir | 0 | |
| Overall Study | NOT COMPLETED | Cohort I - Placebo | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort I - Cidofovir | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort I - Placebo | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort II - Cidofovir | 1 | 5 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort II - Placebo | 0 | 3 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Cohort I - Cidofovir | 1 | 9 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | Cohort I - Placebo | 0 | 5 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Cohort II - Cidofovir | 0 | 5 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Cohort II - Placebo | 0 | 3 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort I - Cidofovir | 1 | 9 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort I - Placebo | 0 | 5 | 0 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I - Cidofovir | ||
| Total, all-cause mortality | Cohort I - Placebo | ||
| Total, all-cause mortality | Cohort II - Cidofovir | ||
| Total, all-cause mortality | Cohort II - Placebo | ||
| Total, other adverse events | Cohort I - Cidofovir | 6 | 9 |
| Total, other adverse events | Cohort I - Placebo | 4 | 5 |
| Total, other adverse events | Cohort II - Cidofovir | 3 | 5 |
| Total, other adverse events | Cohort II - Placebo | 2 | 3 |
| Total, serious adverse events | Cohort I - Cidofovir | 0 | 9 |
| Total, serious adverse events | Cohort I - Placebo | 1 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21692673 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00138424
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