Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726816
• Other study ID #: 009-KOA-1201i
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2012
• Last updated: May 1, 2017
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2017
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

• Screening period (4 week)

• Double blind treatment period (16 weeks)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Probucol 250mg/day
Probucol 250mg + Placebo
• Probucol 500mg/day
Probucol 500mg + Placebo
• Placebo
Probucol matching placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Cholesterol	The change in the Total cholesterol from baseline to the end of treatment(16 week)	16 week
Other	Triglyceride	The change in the Triglyceride from baseline to the end of treatment(16 week)	16 week
Other	LDL-C	The change in the LDL-C from baseline to the end of treatment(16 week)	16 week
Other	HDL-C	The change in the HDL-C from baseline to the end of treatment(16 week)	16 week
Other	oxidized LDL	The change in the oxidized LDL from baseline to the end of treatment(16 week)	16 week
Other	d-ROM	The change in the d-ROM from baseline to the end of treatment(16 week)	16 week
Other	urinary fibronectin	The change in the urinary fibronectin from baseline to the end of treatment(16 week)	16 week
Other	urinary transferrin	The change in the urinary transferrin from baseline to the end of treatment(16 week)	16 week
Other	insulin	The change in the insulin from baseline to the end of treatment(16 week)	16 week
Other	c-peptide	The change in the c-peptide from baseline to the end of treatment(16 week)	16 week
Primary	A/C ratio	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	Serum creatinine	The change in the Serum creatinine from baseline to the end of treatment.	16 week
Secondary	eGFR	The change in the eGFR from baseline to the end of treatment(16 week)	16 week
Secondary	cystatin C	The change in the cystatin C from baseline to the end of treatment(16 week)	16 week
Secondary	urine albumin	The change in the urine albumin from baseline to the end of treatment(16 week)	16 week
Secondary	P/C ratio	The change in the P/C ratio from baseline to the end of treatment(16 week)	16 week