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Statin Therapy in Patients With Early Stage ADPKD

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ClinicalTrials.gov Identifier: NCT03273413
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
ADPKD Autosomal Dominant Polycystic Kidney Drug: Pravastatin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel study design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Therapy in Patients With Early Stage ADPKD
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.
Drug: Placebo
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.
Drug: Pravastatin
Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273413


Contacts
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Contact: Diana George 303-724-1684 diana.george@ucdenver.edu
Contact: Nina Bispham, MS 303-724-1692 nina.bispham@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Denver, Colorado, United States, 80045
Contact: Nina Z Bispham, MS    303-724-1692    nina.bispham@ucdenver.edu   
Contact: Beverly Farmer, RN    303-724-7790    beverly.farmer@ucdenver.edu   
Principal Investigator: Michel B Chonchol, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Michel Chonchol, MD University of Colorado, Denver

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03273413     History of Changes
Other Study ID Numbers: 17-0678
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Colorado, Denver:
Pravastatin
Statin
Additional relevant MeSH terms:
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Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents