Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis

NCT02886299 | Completed Phase 4

• 1 other identifier: CL (746)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment.

Conditions

Fenofibrate/Simvastatin Comparison

Keywords

Fibrates; Statins; Hemodialysis; Dyslipidemia; Improved Oxidative Stress; Egypt

Outcome Measures

Primary Outcomes (2)

• oxidative stress markers (serum ox-LDL and GSH-Px)

  16 weeks

• C-reactive protein

  16 weeks

Study Arms (2)

Fenofibrate group

ACTIVE COMPARATOR

Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).

Drug: Fenofibrate

Simvastatin group

ACTIVE COMPARATOR

Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).

Drug: Simvastatin

Interventions

Fenofibrate DRUG

Fenofibrate group

Simvastatin DRUG

Simvastatin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Chronic hemodialysis patients with 3 dialysis sessions per week.
• Lipid profile:
• Total Cholesterol ≥ 200 mg/dl or LDL ≥ 130 mg/dl.
• Triglycerides ≥ 150 mg/dl.

You may not qualify if:

• Previous intolerance to fibrates or statins.
• Use of any fibrates or statins within 6 months prior to study.
• Hypothyroidism.
• Active liver disease \[unexplained persistent increase in liver enzymes (ALT \& AST \> 2x ULN)\].
• Uncontrolled hypertension.
• History of MI or coronary bypass surgery in last 3 months.
• Muscle toxicity (Phosphocreatine kinase (CPK) \> 2x ULN).
• Gall bladder disease.
• Use of any immunosuppressant or steroid.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fenofibrate; Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09