Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Korea Otsuka Pharmaceutical Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01726816
First received: October 31, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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

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

Condition Intervention Phase
Diabetic Nephropathy
Drug: Probucol 250mg/day
Drug: Probucol 500mg/day
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • A/C ratio [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the A/C ratio from baseline to the end of treatment(16 week) [Time Frame: baseline to 16 weeks]


Secondary Outcome Measures:
  • Serum creatinine [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the Serum creatinine from baseline to the end of treatment.

  • eGFR [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the eGFR from baseline to the end of treatment(16 week)

  • cystatin C [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the cystatin C from baseline to the end of treatment(16 week)

  • urine albumin [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the urine albumin from baseline to the end of treatment(16 week)

  • P/C ratio [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the P/C ratio from baseline to the end of treatment(16 week)


Other Outcome Measures:
  • Total Cholesterol [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the Total cholesterol from baseline to the end of treatment(16 week)

  • Triglyceride [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the Triglyceride from baseline to the end of treatment(16 week)

  • LDL-C [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the LDL-C from baseline to the end of treatment(16 week)

  • HDL-C [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the HDL-C from baseline to the end of treatment(16 week)

  • oxidized LDL [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the oxidized LDL from baseline to the end of treatment(16 week)

  • d-ROM [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the d-ROM from baseline to the end of treatment(16 week)

  • urinary fibronectin [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the urinary fibronectin from baseline to the end of treatment(16 week)

  • urinary transferrin [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the urinary transferrin from baseline to the end of treatment(16 week)

  • insulin [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the insulin from baseline to the end of treatment(16 week)

  • c-peptide [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    The change in the c-peptide from baseline to the end of treatment(16 week)


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probucol 250mg/day
Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Drug: Probucol 250mg/day
Probucol 250mg + Placebo
Other Name: 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 Name: 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 Name: placebo 2 tablets, 16 weeks

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726816

Contacts
Contact: Jaejin Nah jjnah@otsuka.co.kr
Contact: Mihwa Kim

Locations
Korea, Republic of
The Catholic university of Korea, Bucheon St. Mary's Hospital Not yet recruiting
Bucheon, Korea, Republic of
Principal Investigator: SungRae Kim, MD.PhD.         
Yeungnam University Medical Center Recruiting
DaeGu, Korea, Republic of
Principal Investigator: Hyoung Woo LEE, MD.PhD.         
Kyungpook National University Not yet recruiting
DaeGu, Korea, Republic of
Principal Investigator: In Kyu Lee, MD.PhD.         
Inha University Hospital Recruiting
InCheon, Korea, Republic of
Principal Investigator: MoonSuk Nam, MD.PhD.         
Gil Hospital Recruiting
Incheon, Korea, Republic of
Principal Investigator: IeByung Park         
Chonbuk national University Hospital Recruiting
JeonJu, Korea, Republic of
Principal Investigator: TaeSon Park, MD.PhD.         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Bong Soo Cha, MD.PhD         
Samsumg Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: MoonKyu Lee, MD.PhD.         
Sub-Investigator: JiChul Bae, MD         
Sub-Investigator: SungHwan Seo, MD         
Sub-Investigator: SeWon Kim, MD         
Sub-Investigator: SangMan Chin, MD         
Sub-Investigator: NaKyung Kim, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Cheol Young Park, MD.PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sei Hyun Baek, MD.PhD.         
Kangnam Sacred Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: JaeMyung Yu         
Eulji Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: KyungAh Han         
Kyunghee Univ Hospital at Kangdong Recruiting
Seoul, Korea, Republic of
Principal Investigator: Yuchul Hwang         
Seoul National University Bundang Hospital Not yet recruiting
SungNam, Korea, Republic of
Principal Investigator: Sung-Hee Choi, MD.PhD.         
St. Vincent Hospital Recruiting
Suwon, Korea, Republic of
Principal Investigator: SeungHyun Ko         
UIJEONGBU ST. MARY's HOSPITAL Not yet recruiting
Uijeongbu, Korea, Republic of
Contact: TaeSeo Son, MD.PhD         
Principal Investigator: TaeSeo Son, MD.PhD         
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Study Chair: MoonKyu Lee, professor Samsung Medical Center
  More Information

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01726816     History of Changes
Other Study ID Numbers: 009-KOA-1201i
Study First Received: October 31, 2012
Last Updated: September 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Diabetic nephropathy
Albumin creatinine ratio
Probucol

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014