A multicenter, randomized, double blind, double dummy, 16-week, Parallel, Placebo controlled study to evaluate the efficacy and safety of Probucol in patients with nephropathy due to type 2 diabetes.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000927
- Lead Sponsor
- Korea Otsuka Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1)Outpatients with type 2 diabetes (duration of illness more than 5 years) at age of 20 to 80 years at the time of screening visit
2)Patients with overt albuminuria at the time of screening visit
-A/C Ratio = 300mg/g Cr
3)Subjects administered with ACEI and/or ARB without changing dosage for more than 3 months prior to the screening visit
4)Subjects administered with statins without changing dosage for more than 3 months prior to the screening visit or subjects who are currently not administering statins and have no plan to administer statins during the clinical trial
5)Subjects with eGFR above 15 mL/min and under 90 mL/min at the time of screening visit
6)Subjects who agreed to participate in this clinical trial with written ICF prior to the screening visit
1)Type 1 DM or gestational diabetes
2)Subjects having experience of dialysis or kidney transplantation prior to screening visit
3)Subjects with ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
4)Cardiac damage (subjects showing abnormal levels of Troponin I)
5)Subjects with medical history of cardiac syncope or primary syncope
6)Subjects having abnormally prolonged QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec).
7)Pregnant or lactating woman before screening or registration
8)Subjects with inflammatory bowel disease (ulcerative colitis, Crohn's disease)
9)Intra,external hepatic cholestatsis
10)Congestive heart failure
11)Subjects with myocardial infarction or cerebral infarction within the latest 6 months since the screening
12)Subjects with heart failure diagnosed of NYHA grade III-IV status who is under treatment or needs treatment
13)AST or ALT is 3 times higher than the upper limit of the normal range at the screening visit
14)Active hepatitis or liver cirrhosis
15)Subjects with Hyperkalemia (serum potassium concentration exceeding 5.5 mEq/L)
16)Subjects with renal artery stenosis
17)Subjects having history of malignancy within the 5 years at the time of screening visit(except for treated basal cells carcinoma or squamous cell carcinoma)
18)Subjects having urinary tract disease as follows (urinary tract infection, neurogenic bladder)
19)Subjects having kidney disease as follows (nephritis, chronic glomerulonephritis or polycystic kidney disease)
20)Subjects having hypersensitivity or allergic reaction to Probucol
21)Subjects having HbA1c exceeding 9% at the time of screening
22)Subjects having systolic BP = 160 mmHg or diastolic BP = 100 mmHg at the time of screening
23)Subjects taken probucol within 3 months prior to screening
24)Subjects who has received another IMP within 3 months prior to screening
25)Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial due to reasons like alcohol or drug abuse
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Albumin Creatinine Ratio
- Secondary Outcome Measures
Name Time Method serum creatinine;Urine albumin;PCR (Protein Creatinine Ratio)