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Diabetic NephropathyPhase 2NCT01726816

Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

A Phase 2 study testing Probucol 250mg/day and Probucol 500mg/day in people with Diabetic Nephropathy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 16 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Diabetic Nephropathy
What is being tested?
Probucol 250mg/day and Probucol 500mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
16 sitesSouth Korea
Study dates
Oct 2012to Sep 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 15 mL/min ≤ eGFR ≤ 90 mL min
  • Subjects must be willing and able to give signed and dated written informed consent.

Who cannot join

  • 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
Show all 25Show fewer
  • 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)
  • 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
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • The Catholic university of Korea, Bucheon St. Mary's Hospital

    Bucheon-si

  • Kyungpook National University

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Gil Hospital

    Incheon

  • Inha University Hospital

    Incheon

  • Chonbuk national University Hospital

    Jeonju

  • Eulji Hospital

    Seoul

  • Kangbuk Samsung Hospital

    Seoul

  • Kangnam Sacred Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyunghee Univ Hospital at Kangdong

    Seoul

  • Samsumg Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • Seoul National University Bundang Hospital

    SungNam

  • St. Vincent Hospital

    Suwon

  • UIJEONGBU ST. MARY's HOSPITAL

    Uijeongbu-si

Other trials in South Korea

About this study

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.

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

  • Screening period (4 week)
  • Double blind treatment period (16 weeks)
Read the detailed 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
Being tested
Probucol 250mg/day, Probucol 500mg/day, Placebo
Keywords
Diabetic nephropathy, Albumin creatinine ratio, Probucol
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probucol 250mg/dayDrug

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

    Probucol 250mg + Placebo

  • Probucol 500mg/dayDrug

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

    Probucol 500mg + Placebo

  • PlaceboDrug

    Also called placebo 2 tablets, 16 weeks

    Probucol matching placebo

Study groups in NCT01726816
Study groupRoleWhat they receive
Probucol 250mg/dayExperimentalProbucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Receives: Drug: Probucol 250mg/day
Probucol 500mg/dayExperimentalProbucol 500mg group: probucol 250mg 2 tablets, 16 weeks
Receives: Drug: Probucol 500mg/day
PlaceboPlacebo comparatorPlacebo group: placebo 2 tablets, 16 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: 16 week

Secondary outcomes (5)

  1. Serum creatinine

    The change in the Serum creatinine from baseline to the end of treatment.

    Measured: 16 week

  2. eGFR

    The change in the eGFR from baseline to the end of treatment(16 week)

    Measured: 16 week

  3. cystatin C

    The change in the cystatin C from baseline to the end of treatment(16 week)

    Measured: 16 week

  4. urine albumin

    The change in the urine albumin from baseline to the end of treatment(16 week)

    Measured: 16 week

  5. P/C ratio

    The change in the P/C ratio from baseline to the end of treatment(16 week)

    Measured: 16 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01726816
Sponsor's protocol ID
009-KOA-1201i
Status last verified
May 2017
First submitted
31 Oct 2012
Last updated
3 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27493100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probucol 250mg/day and Probucol 500mg/day in people with Diabetic Nephropathy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A/C ratio (time frame: 16 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01726816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.

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