Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

May 1, 2017 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

A Phase II, Multicenter, Randomized, Double Blind, Double-dummy, 16-week, Placebo Controlled Study to Evaluate the Efficacy and Safety of Probucol in Patients With Nephropathy Due to Type 2 Diabetes.

This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.

  • Screening period (4 week)
  • Double blind treatment period (16 weeks)

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

  1. Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner
  2. Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks

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.
126

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 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
      • DaeGu, Korea, Republic of
        • Kyungpook National University
      • DaeGu, Korea, Republic of
        • Yeungnam University Medical Center
      • InCheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Gil Hospital
      • JeonJu, Korea, Republic of
        • Chonbuk National University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Eulji Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of
        • Kangnam Sacred Hospital
      • Seoul, Korea, Republic of
        • Kyunghee Univ Hospital at Kangdong
      • Seoul, Korea, Republic of
        • Samsumg Medical Center
      • SungNam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Suwon, Korea, Republic of
        • St. Vincent Hospital
      • Uijeongbu, Korea, Republic of
        • Uijeongbu St. Mary's Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is male or female diagnosed with type 2 diabetes mellitus and must be aged 20 to 75 years at the time of screening visit
  2. Urinary albumin excretion > 300 mg/g Cr at screening visit
  3. Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
  4. Subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin)
  5. 15 mL/min ≤ eGFR ≤ 90 mL min
  6. Subjects must be willing and able to give signed and dated written informed consent.

Exclusion Criteria:

  1. Type 1 DM or gestational diabetes
  2. Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
  3. Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
  4. Cardiac damage (abnormally levels of Troponin I)
  5. Subject with medical history of cardiac syncope or primary syncope
  6. Has condition that may prolong QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec) at screening
  7. Pregnant or lactating woman before randomization
  8. Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
  9. Cholestasis
  10. Congestive heart failure
  11. Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
  12. Subjects has a diagnosis of NYHA grade III-IV status
  13. AST or ALT is 3.0 times higher than the upper limit of the normal range
  14. Active hepatitis Or Liver cirrhosis
  15. Subjects with Hyperkalemia (K>5.5 mEq/L)
  16. Subjects with Renal Artery stenosis
  17. Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
  18. Urinary tract disease (urinary tract infection, Neurogenic bladder)
  19. Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
  20. Has an allergic history to probucol
  21. HbA1c > 9%
  22. Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
  23. Subjects taken probucol within 3 months prior to Screening
  24. The subject has received an investigational product or biological agent within 3 months prior to screening
  25. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial

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: Double

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.
Experimental: Probucol 250mg/day
Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Drug: Probucol 250mg/day
Probucol 250mg + Placebo
Other Names:
  • Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Experimental: Probucol 500mg/day
Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks
Drug: Probucol 500mg/day
Probucol 500mg + Placebo
Other Names:
  • Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks
Placebo Comparator: Placebo
Placebo group: placebo 2 tablets, 16 weeks
Drug: Placebo
Probucol matching placebo
Other Names:
  • placebo 2 tablets, 16 weeks

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
Measure Description
Time Frame
A/C ratio
Time Frame: 16 week
The change in the A/C ratio from baseline to the end of treatment(16 week) [Time Frame: baseline to 16 weeks]
16 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum creatinine
Time Frame: 16 week
The change in the Serum creatinine from baseline to the end of treatment.
16 week
eGFR
Time Frame: 16 week
The change in the eGFR from baseline to the end of treatment(16 week)
16 week
cystatin C
Time Frame: 16 week
The change in the cystatin C from baseline to the end of treatment(16 week)
16 week
urine albumin
Time Frame: 16 week
The change in the urine albumin from baseline to the end of treatment(16 week)
16 week
P/C ratio
Time Frame: 16 week
The change in the P/C ratio from baseline to the end of treatment(16 week)
16 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: 16 week
The change in the Total cholesterol from baseline to the end of treatment(16 week)
16 week
Triglyceride
Time Frame: 16 week
The change in the Triglyceride from baseline to the end of treatment(16 week)
16 week
LDL-C
Time Frame: 16 week
The change in the LDL-C from baseline to the end of treatment(16 week)
16 week
HDL-C
Time Frame: 16 week
The change in the HDL-C from baseline to the end of treatment(16 week)
16 week
oxidized LDL
Time Frame: 16 week
The change in the oxidized LDL from baseline to the end of treatment(16 week)
16 week
d-ROM
Time Frame: 16 week
The change in the d-ROM from baseline to the end of treatment(16 week)
16 week
urinary fibronectin
Time Frame: 16 week
The change in the urinary fibronectin from baseline to the end of treatment(16 week)
16 week
urinary transferrin
Time Frame: 16 week
The change in the urinary transferrin from baseline to the end of treatment(16 week)
16 week
insulin
Time Frame: 16 week
The change in the insulin from baseline to the end of treatment(16 week)
16 week
c-peptide
Time Frame: 16 week
The change in the c-peptide from baseline to the end of treatment(16 week)
16 week

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.
Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: MoonKyu Lee, professor, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2012

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.
April 1, 2014

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.
September 1, 2014

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).
October 31, 2012

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.
November 11, 2012

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.
November 15, 2012

Study Record Updates

Last Update Posted (Actual)

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.
May 3, 2017

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.
May 1, 2017

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.
May 1, 2017

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.
  • 009-KOA-1201i

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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