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

NCT ID: NCT02886299

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-01-31

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.

Detailed Description

This is a prospective randomized open label parallel study.

The selected patients will be randomly allocated to one of two groups

• Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).
• Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).

A careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s).

Monitoring Parameters:

For efficacy, the following parameters are measured:

1. Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula [10] {LDL-C= TC-[HDL + TG\5]). (measured at baseline and every month for 4 months)

2. C-reactive protein (CRP). (measured at baseline and after 4 months)

3. Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at baseline and after 4 months).

For safety: (measured at baseline and every month for 4 months)

1. Observe for signs & symptoms of muscle toxicity and measure phosphocreatine kinase (CPK).

2. Liver function tests: ALT, AST, ALP & albumin.

3. Urea & serum creatinine. (to monitor renal function)

4. Hemoglobin

5. Other measurements: Body mass index (BMI), Blood Pressure, electrolytes (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting.

Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.

Conditions

Fenofibrate/Simvastatin Comparison

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fenofibrate group

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

Group Type: ACTIVE_COMPARATOR

Fenofibrate

Intervention Type: DRUG

Simvastatin group

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

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

Interventions

Fenofibrate

Intervention Type: DRUG

Simvastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Chronic hemodialysis patients with 3 dialysis sessions per week.

3. Lipid profile:

1. Total Cholesterol ≥ 200 mg/dl or LDL ≥ 130 mg/dl.

2. Triglycerides ≥ 150 mg/dl.

Exclusion Criteria

1. Previous intolerance to fibrates or statins.

2. Use of any fibrates or statins within 6 months prior to study.

3. Hypothyroidism.

4. Active liver disease [unexplained persistent increase in liver enzymes (ALT & AST > 2x ULN)].

5. Uncontrolled hypertension.

6. History of MI or coronary bypass surgery in last 3 months.

7. Muscle toxicity (Phosphocreatine kinase (CPK) > 2x ULN).

8. Gall bladder disease.

9. Use of any immunosuppressant or steroid.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Mohammed Abdel Magid Abdel Hamid

Teaching Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CL (746)

Identifier Type: -

Identifier Source: org_study_id