Statin Therapy in Patients With Early Stage ADPKD

University of Colorado Denver (CU Denver)

Status and phase: Active, not recruiting; Phase 4

Conditions: Autosomal Dominant Polycystic Kidney; ADPKD

Treatments: Drug: Placebo; Drug: Pravastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03273413

17-0678

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo

Pravastatin

Active Comparator group

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.

Treatment:

Drug: Pravastatin