Statin Therapy in Patients With Early Stage ADPKD

ADPKD Clinical Trial

Official title:

Statin Therapy in Patients With Early Stage ADPKD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03273413
• Other study ID #: 17-0678
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 31, 2017
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• ADPKD
• Autosomal Dominant Polycystic Kidney
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Pravastatin
Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy
• Placebo
Inactive tablet

Locations

Country	Name	City	State
United States	University of Colorado Denver Anschutz Medical Campus	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Blood Vessel Stiffness	Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years	Baseline, 2 years
Primary	Change in Total Kidney Volume	Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment	Baseline, 2 years
Secondary	Change in Renal Blood Flow	Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment	Baseline, 2 years
Secondary	Change in Kidney Function	Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment	Baseline, 2 years
Secondary	Change in Circulating Inflammatory Markers	Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment	Baseline, 2 years
Secondary	Change in Circulating Markers of Oxidative Stress	Plasma levels of oxidative stress markers at baseline and after 2 years of treatment	Baseline, 2 years
Secondary	Change in Urinary Epithelial Cells	Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment	Baseline, 2 years