Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure

NCT02511418 | Completed

• 1 other identifier: 475-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.

Conditions

Hyperlipidemia; Hypertension; Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• Effect of short term HMG-CoA reductase treatment

  Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P \<0.05.

  4 weeks

Interventions

Simvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy
• Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)
• Serum transaminase levels (AST, ALT) 2 times the upper limit of normal
• Clinically significant medical conditions
• Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study
• Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection
• Presence of concomitant renal artery stenosis.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Publications (1)

• Zand L, Torres VE, Larson TS, King BF, Sethi S, Bergstralh EJ, Angioi A, Fervenza FC. Renal hemodynamic effects of the HMG-CoA reductase inhibitors in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant. 2016 Aug;31(8):1290-5. doi: 10.1093/ndt/gfv394. Epub 2015 Nov 27.

  PMID: 26614268 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Hypertension; Kidney Failure, Chronic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 30, 2015
• Primary Completion: January 1, 2007
• Last Updated: March 16, 2023

Record last verified: 2023-03