Trial · NCT00456365
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT00456365, Phase 3, Completed, University of Colorado, Denver; results first posted 2018-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD). Trials, record NCT00456365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00456365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- NCT number
- NCT00456365
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- pravastatin, Placebo
- First posted
- 2007-04-04
- Last updated
- 2018-03-09
- Results first posted
- 2018-03-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume | 3 years | Percent of participants demonstrating 20% or more increase in total kidney volume corrected for height, left ventricular mass index, or urinary albumin excretion over the three year study period |
| Secondary | Percentage Change in Total Kidney Volume Corrected for Height | 3 years | |
| Secondary | Left Ventricular Mass Index | 3 years | left ventricular mass index in g/m\^2 by MRI |
| Secondary | Urinary Albumin Excretion | 3 years |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume | 3 years | Intention to treat | percentage of participants | NUMBER |
| SECONDARY | Percentage Change in Total Kidney Volume Corrected for Height | 3 years | ITT | Percent change | MEAN |
| SECONDARY | Left Ventricular Mass Index | 3 years | g/m^2 | MEAN | |
| SECONDARY | Urinary Albumin Excretion | 3 years | mcg/min | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume | Pravastatin | 69 | percentage of participants | ||
| Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume | Placebo | 88 | percentage of participants | ||
| Percentage Change in Total Kidney Volume Corrected for Height | Pravastatin | 23 | Standard Deviation 3 | Percent change | |
| Percentage Change in Total Kidney Volume Corrected for Height | Placebo | 31 | Standard Deviation 3 | Percent change | |
| Left Ventricular Mass Index | Pravastatin | 60 | Standard Deviation 15 | g/m^2 | |
| Left Ventricular Mass Index | Placebo | 58 | Standard Deviation 13 | g/m^2 | |
| Urinary Albumin Excretion | Pravastatin | 29 | Standard Deviation 39 | mcg/min | |
| Urinary Albumin Excretion | Placebo | 49 | Standard Deviation 99 | mcg/min |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pravastatin | 56 | |
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | COMPLETED | Pravastatin | 49 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | NOT COMPLETED | Pravastatin | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pravastatin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pravastatin | 0 | 56 |
| Total, other adverse events | Placebo | 0 | 54 |
| Total, serious adverse events | Pravastatin | 0 | 56 |
| Total, serious adverse events | Placebo | 0 | 54 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK058793 | Effect of Statin Therapy on Disease Progression in Children with ADPKD | SCHRIER, ROBERT W | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2001 to 2012 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pravastatin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00456365
GET https://conductscience.org/api/trials/v1/NCT00456365/registered