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

September 1, 2016 updated by: Aya Mohammed Abdel Magid Abdel Hamid, Cairo University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
C-reactive protein
Time Frame: 16 weeks
16 weeks
oxidative stress markers (serum ox-LDL and GSH-Px)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL (746)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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