Phase 3
N=110
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney, Autosomal Dominant
Bottom Line
View on ClinicalTrials.gov: NCT00456365 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume — 69; 88 percentage of participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pravastatin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume |
69; 88 | 0.03 sig |
| SECONDARY Percentage Change in Total Kidney Volume Corrected for Height |
23; 31 | 0.02 sig |
| SECONDARY Left Ventricular Mass Index |
60; 58 | 0.69 |
| SECONDARY Urinary Albumin Excretion |
29; 49 | 0.21 |
Summary
The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease (ADPKD).
Eligibility Criteria
Inclusion Criteria
- Age 8-22 years
- Autosomal dominant polycystic kidney disease
- Normal kidney function
Exclusion Criteria
- Abnormal kidney function
- Past allergic history to medications used in study
- Liver disease
- Muscle disease/dystrophy
- Pregnancy, planned pregnancy, or lactation within study period
- Inability to cooperate with or clinical contraindication for magnetic resonance imaging
Data sourced from ClinicalTrials.gov (NCT00456365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.