Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

Otsuka

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: Placebo; Drug: Probucol 500mg/day; Drug: Probucol 250mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01726816

009-KOA-1201i

Details and patient eligibility

About

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

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

Full 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

Enrollment: 126 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 3 patient groups, including a placebo group

Probucol 250mg/day

Experimental group

Description:

Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks

Treatment:

Drug: Probucol 250mg/day

Probucol 500mg/day

Experimental group

Description:

Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks

Treatment:

Drug: Probucol 500mg/day

Placebo

Placebo Comparator group

Description:

Placebo group: placebo 2 tablets, 16 weeks

Treatment:

Drug: Placebo