Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy
This study is currently recruiting participants.
Verified November 2012 by Korea Otsuka Pharmaceutical Co.,Ltd.
Sponsor:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01726816
First received: October 31, 2012
Last updated: November 11, 2012
Last verified: November 2012
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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: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (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:
- Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner
- 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:
- The subject is male or female diagnosed with type 2 diabetes mellitus(period prevalence more than 5 years) and must be aged 20 to 75 years at the time of screening visit
- Urinary albumin excretion > 300 mg/g Cr at screening visit
- Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
- 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)
- 15 mL/min ≤ eGFR ≤ 50 mL min
- Subjects must be willing and able to give signed and dated written informed consent.
Exclusion Criteria:
- Type 1 DM or gestational diabetes
- Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
- Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
- Cardiac damage (abnormally levels of Troponin I or Troponin T)
- Subject with medical history of cardiac syncope or primary syncope
- Has condition that may prolong QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec) at screening
- Pregnant or lactating woman before randomization
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- Cholestasis
- Congestive heart failure
- Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
- Subjects has a diagnosis of NYHA grade III-IV status
- AST or ALT is 3.0 times higher than the upper limit of the normal range
- Active hepatitis Or Liver cirrhosis
- Subjects with Hyperkalemia (K>5.0 mEq/L)
- Subjects with Renal Artery stenosis
- Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
- Urinary tract disease (urinary tract infection, Neurogenic bladder)
- Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
- Has an allergic history to probucol
- 6.5% > HbA1 or HbA1c > 9%
- Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
- Subjects taken probucol within 3 months prior to Screening
- The subject has received an investigational product or biological agent within 3 months prior to screening
- Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726816
Contacts
| Contact: Moonkyu Lee, MD.PhD | leemk@skku.edu |
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. | |
| Kyungpook National University | Not yet recruiting |
| DaeGu, Korea, Republic of | |
| Principal Investigator: In Kyu Lee, MD.PhD. | |
| Yeungnam University Medical Center | Recruiting |
| DaeGu, Korea, Republic of | |
| Principal Investigator: Hyoung Woo LEE, MD.PhD. | |
| Inha University Hospital | Not yet recruiting |
| InCheon, Korea, Republic of | |
| Principal Investigator: MoonSuk Nam, MD.PhD. | |
| Chonbuk national University Hospital | Not yet recruiting |
| JeonJu, Korea, Republic of | |
| Principal Investigator: TaeSon Park, 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 | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Bong Soo Cha, MD.PhD | |
| Korea University Guro Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Sei Hyun Baek, MD.PhD. | |
| Seoul National University Bundang Hospital | Not yet recruiting |
| SungNam, Korea, Republic of | |
| Principal Investigator: Sung-Hee Choi, MD.PhD. | |
| 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: | November 11, 2012 |
| 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 May 16, 2013