Phase 3
Completed N=110
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney, Autosomal Dominant
Source: ClinicalTrials.gov NCT00456365 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume — 69; 88 percentage of participants — p=0.03
◆ Published Evidence
Emerging
8citations · ~4 / year
Interventions for preventing the progression of autosomal dominant polycystic kidney disease.
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).
Linked Publications
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Interventions for preventing the progression of autosomal dominant polycystic kidney disease.
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 |
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) and the linked publication. 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. Informational only — not medical advice.