Statin Therapy in Patients With Early Stage ADPKD
Primary Purpose
ADPKD, Autosomal Dominant Polycystic Kidney
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pravastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ADPKD focused on measuring Pravastatin, Statin
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ADPKD
- Total kidney volume >500 mL
- Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73m^2
- Controlled blood pressure <140/80 mmHg
Exclusion Criteria:
- Uncontrolled hypertension
- Diabetes mellitus
- Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
- Unstable angina
- Coronary artery disease
- Prior ischemic stroke
- Other clinical indication for a statin
- History of hospitalizations within the last 3 months
- Hepatic impairment or liver function abnormalities
- Secondary hypercholesterolemia or hypocholesterolemia
- Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
- Hypersensitivity to statins
- Immunosuppressive therapy within the last year
- Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
- Hypersensitivity to iodine
- Pregnant or breast feeding
- Current tobacco use
- Alcohol abuse or dependence
Sites / Locations
- University of Colorado Denver Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Pravastatin
Arm Description
Participants will receive inactive 40 mg tablets of placebo everyday for 6 weeks. If well tolerated, participants will continue taking inactive 40 mg dose of placebo everyday for 2 years.
Participants will receive 40 mg tablets of pravastatin everyday for 6 weeks. If well tolerated, participants will continue taking 40 mg dose of pravastatin everyday for 2 years.
Outcomes
Primary Outcome Measures
Change in Total Kidney Volume
Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
Secondary Outcome Measures
Change in Renal Blood Flow
Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment
Change in Kidney Function
Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment
Change in Circulating Inflammatory Markers
Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment
Change in Circulating Markers of Oxidative Stress
Plasma levels of oxidative stress markers at baseline and after 2 years of treatment
Change in Urinary Epithelial Cells
Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment
Full Information
NCT ID
NCT03273413
First Posted
September 1, 2017
Last Updated
March 13, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03273413
Brief Title
Statin Therapy in Patients With Early Stage ADPKD
Official Title
Statin Therapy in Patients With Early Stage ADPKD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.
Detailed Description
This is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with ADPKD by evaluating 1) kidney volume as measured by kidney magnetic resonance imaging (MRI); 2) renal blood flow as measured by kidney magnetic resonance angiography (MRA); 3) kidney function as assessed by Glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in ADPKD; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. These parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with ADPKD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADPKD, Autosomal Dominant Polycystic Kidney
Keywords
Pravastatin, Statin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, parallel study design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive inactive 40 mg tablets of placebo everyday for 6 weeks. If well tolerated, participants will continue taking inactive 40 mg dose of placebo everyday for 2 years.
Arm Title
Pravastatin
Arm Type
Active Comparator
Arm Description
Participants will receive 40 mg tablets of pravastatin everyday for 6 weeks. If well tolerated, participants will continue taking 40 mg dose of pravastatin everyday for 2 years.
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive tablet
Primary Outcome Measure Information:
Title
Change in Total Kidney Volume
Description
Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Secondary Outcome Measure Information:
Title
Change in Renal Blood Flow
Description
Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Title
Change in Kidney Function
Description
Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Title
Change in Circulating Inflammatory Markers
Description
Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Title
Change in Circulating Markers of Oxidative Stress
Description
Plasma levels of oxidative stress markers at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Title
Change in Urinary Epithelial Cells
Description
Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment
Time Frame
Baseline, 2 years
Other Pre-specified Outcome Measures:
Title
Change in Blood Vessel Stiffness
Description
Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years
Time Frame
Baseline, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ADPKD
Total kidney volume >500 mL
Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73m^2
Controlled blood pressure <140/80 mmHg
Exclusion Criteria:
Uncontrolled hypertension
Diabetes mellitus
Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
Unstable angina
Coronary artery disease
Prior ischemic stroke
Other clinical indication for a statin
History of hospitalizations within the last 3 months
Hepatic impairment or liver function abnormalities
Secondary hypercholesterolemia or hypocholesterolemia
Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
Hypersensitivity to statins
Immunosuppressive therapy within the last year
Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
Hypersensitivity to iodine
Pregnant or breast feeding
Current tobacco use
Alcohol abuse or dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Chonchol, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver Anschutz Medical Campus
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24721893
Citation
Cadnapaphornchai MA, George DM, McFann K, Wang W, Gitomer B, Strain JD, Schrier RW. Effect of pravastatin on total kidney volume, left ventricular mass index, and microalbuminuria in pediatric autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2014 May;9(5):889-96. doi: 10.2215/CJN.08350813. Epub 2014 Apr 10.
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Statin Therapy in Patients With Early Stage ADPKD
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