Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
2 other identifiers
interventional
110
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
March 9, 2018
CompletedMarch 9, 2018
February 1, 2018
5.9 years
March 12, 2007
May 27, 2014
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume
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
3 years
Secondary Outcomes (3)
Percentage Change in Total Kidney Volume Corrected for Height
3 years
Left Ventricular Mass Index
3 years
Urinary Albumin Excretion
3 years
Study Arms (2)
Pravastatin
EXPERIMENTALPravastatin
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
Eligibility Criteria
You may qualify if:
- Age 8-22 years
- Autosomal dominant polycystic kidney disease
- Normal kidney function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, 80262, United States
Related Publications (7)
Schrier RW. Optimal care of autosomal dominant polycystic kidney disease patients. Nephrology (Carlton). 2006 Apr;11(2):124-30. doi: 10.1111/j.1440-1797.2006.00535.x.
PMID: 16669974BACKGROUNDShamshirsaz AA, Reza Bekheirnia M, Kamgar M, Johnson AM, McFann K, Cadnapaphornchai M, Nobakhthaghighi N, Schrier RW. Autosomal-dominant polycystic kidney disease in infancy and childhood: progression and outcome. Kidney Int. 2005 Nov;68(5):2218-24. doi: 10.1111/j.1523-1755.2005.00678.x.
PMID: 16221221BACKGROUNDTaylor M, Johnson AM, Tison M, Fain P, Schrier RW. Earlier diagnosis of autosomal dominant polycystic kidney disease: importance of family history and implications for cardiovascular and renal complications. Am J Kidney Dis. 2005 Sep;46(3):415-23. doi: 10.1053/j.ajkd.2005.05.029.
PMID: 16129202BACKGROUNDCadnapaphornchai MA, Fick-Brosnahan GM, Duley I, Johnson AM, Strain JD, DeGroff CG, Schrier RW. Design and baseline characteristics of participants in the study of antihypertensive therapy in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). Contemp Clin Trials. 2005 Apr;26(2):211-22. doi: 10.1016/j.cct.2005.01.001.
PMID: 15837441BACKGROUNDFick-Brosnahan GM, Belz MM, McFann KK, Johnson AM, Schrier RW. Relationship between renal volume growth and renal function in autosomal dominant polycystic kidney disease: a longitudinal study. Am J Kidney Dis. 2002 Jun;39(6):1127-34. doi: 10.1053/ajkd.2002.33379.
PMID: 12046022BACKGROUNDKelleher CL, McFann KK, Johnson AM, Schrier RW. Characteristics of hypertension in young adults with autosomal dominant polycystic kidney disease compared with the general U.S. population. Am J Hypertens. 2004 Nov;17(11 Pt 1):1029-34. doi: 10.1016/j.amjhyper.2004.06.020.
PMID: 15533729BACKGROUNDSt Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PMID: 39356039DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melissa Cadnapaphornchai, MD
- Organization
- PKD Research Group, University of Colorado Anschutz Medical Campus
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa A Cadnapaphornchai, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Robert W Schrier, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2007
First Posted
April 4, 2007
Study Start
November 1, 2006
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 9, 2018
Results First Posted
March 9, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share