- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273413
Statin Therapy in Patients With Early Stage ADPKD
April 9, 2024 updated by: University of Colorado, Denver
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diana George
- Phone Number: 303-724-1684
- Email: diana.george@ucdenver.edu
Study Contact Backup
- Name: Nina Bispham, MS
- Phone Number: 303-724-1692
- Email: nina.bispham@ucdenver.edu
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80045
- University of Colorado Denver Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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.
|
Inactive tablet
|
Active Comparator: Pravastatin
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.
|
Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Kidney Volume
Time Frame: Baseline, 2 years
|
Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Renal Blood Flow
Time Frame: Baseline, 2 years
|
Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Change in Kidney Function
Time Frame: Baseline, 2 years
|
Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Change in Circulating Inflammatory Markers
Time Frame: Baseline, 2 years
|
Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Change in Circulating Markers of Oxidative Stress
Time Frame: Baseline, 2 years
|
Plasma levels of oxidative stress markers at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Change in Urinary Epithelial Cells
Time Frame: Baseline, 2 years
|
Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment
|
Baseline, 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Vessel Stiffness
Time Frame: Baseline, 2 years
|
Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years
|
Baseline, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Chonchol, MD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2017
Primary Completion (Actual)
March 25, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 1, 2017
First Posted (Actual)
September 6, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pravastatin
Other Study ID Numbers
- 17-0678
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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