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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT02886299

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fenofibrate/Simvastatin Comparison	Drug: Fenofibrate Drug: Simvastatin	Phase 4

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:

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

Observe for signs & symptoms of muscle toxicity and measure phosphocreatine kinase (CPK).
Liver function tests: ALT, AST, ALP & albumin.
Urea & serum creatinine. (to monitor renal function)
Hemoglobin
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Study of Effects and Safety of Intermittent Low Dose Therapy of Fenofibrate and Simvastatin on Chronic Hemodialysis Patients

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fenofibrate group Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).	Drug: Fenofibrate
Active Comparator: Simvastatin group Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).	Drug: Simvastatin

Arm

Intervention/Treatment

Active Comparator: Fenofibrate group

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

Drug: Fenofibrate

Active Comparator: Simvastatin group

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

Drug: Simvastatin

Outcome Measures

Primary Outcome Measures

oxidative stress markers (serum ox-LDL and GSH-Px) [16 weeks]
C-reactive protein [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.