Statin Therapy in Patients With Early Stage ADPKD

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Brief Title

Statin Therapy in Patients With Early Stage ADPKD

Official Title

Statin Therapy in Patients With Early Stage ADPKD

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in Total Kidney Volume

Secondary Outcome

 Change in Renal Blood Flow

Condition

ADPKD

Intervention

Pravastatin

Study Arms / Comparison Groups

 Placebo
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

August 31, 2017

Completion Date

December 2021

Primary Completion Date

December 2021

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
      

Gender

All

Ages

25 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Michel Chonchol, MD, 303-724-1684, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03273413

Organization ID

17-0678


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver


Study Sponsor

Michel Chonchol, MD, Principal Investigator, University of Colorado, Denver


Verification Date

November 2020