Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy
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.
1 other identifier
interventional
126
1 country
16
Brief Summary
This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.
- Screening period (4 week)
- Double blind treatment period (16 weeks)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2012
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 3, 2017
May 1, 2017
1.5 years
October 31, 2012
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Serum creatinine
16 week
eGFR
16 week
cystatin C
16 week
urine albumin
16 week
P/C ratio
16 week
Other Outcomes (10)
Total Cholesterol
16 week
Triglyceride
16 week
LDL-C
16 week
- +7 more other outcomes
Study Arms (3)
Probucol 250mg/day
EXPERIMENTALProbucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Probucol 500mg/day
EXPERIMENTALProbucol 500mg group: probucol 250mg 2 tablets, 16 weeks
Placebo
PLACEBO COMPARATORPlacebo group: placebo 2 tablets, 16 weeks
Interventions
Probucol 250mg + Placebo
Probucol 500mg + Placebo
Eligibility Criteria
You may qualify if:
- 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
- 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)
- mL/min ≤ eGFR ≤ 90 mL min
- Subjects must be willing and able to give signed and dated written informed consent.
You may not qualify if:
- 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)
- 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\>5.5 mEq/L)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
The Catholic university of Korea, Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Kyungpook National University
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Gil Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk national University Hospital
Jeonju, South Korea
Eulji Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Kangnam Sacred Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyunghee Univ Hospital at Kangdong
Seoul, South Korea
Samsumg Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
SungNam, South Korea
St. Vincent Hospital
Suwon, South Korea
UIJEONGBU ST. MARY's HOSPITAL
Uijeongbu-si, South Korea
Related Publications (1)
Jin SM, Han KA, Yu JM, Sohn TS, Choi SH, Chung CH, Park IeB, Rhee EJ, Baik SH, Park TS, Lee IK, Ko SH, Hwang YC, Cha BS, Lee HW, Nam MS, Lee MK. Probucol in Albuminuric Type 2 Diabetes Mellitus Patients on Renin-Angiotensin System Blockade: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Arterioscler Thromb Vasc Biol. 2016 Oct;36(10):2108-14. doi: 10.1161/ATVBAHA.116.308034. Epub 2016 Aug 4.
PMID: 27493100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
MoonKyu Lee, professor
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 15, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
September 1, 2014
Last Updated
May 3, 2017
Record last verified: 2017-05