AzTrials
AzTrials

Diabetic NephropathyPhase 4NCT01252056

A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy

A Phase 4 study testing Probucol and Probucol and Cilostazol in people with Diabetic Nephropathy, run by Otsuka Beijing Research Institute at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetic Nephropathy
What is being tested?
Probucol and Probucol and Cilostazol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
1 siteChina
Study dates
Mar 2010to Dec 2012
Phase
Phase 4
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 40~75 years old
  • Type 2 diabetes mellitus above 6 months
  • HbA1c ≤8%
  • Twice (above 2-week interval) confirmed urinary albumin at 30-3000µg/mg.cre
  • Receive routine dosage ACEI or ARB treatment above 2 months, and the dosage has been fixed for at least 1 month
  • LDL-C>100 mg/dL (2.60 mmol/L) and/ or hyperlipidemia patients with Statins treatment
  • Free will to sign the informed consent form

Who cannot join

  • Has an allergic history to investigational drugs
  • Receive antilipemic agents (except Statins) within the latest 2 months, including Probucol
  • Receive antiplatelet or anticoagulation agents (except Aspirin) within the latest 2 months, including Cilostazol
  • Rapid progression of nephropathy within the latest 3 months
  • Kidney disease caused by other reasons according to medical history
  • Serum potassium level less than 3.5 mEq/L or more than 5.5 mEq/L
Show all 19Show fewer
  • Hemorrhagic tendency or hemorrhagic disease (such as alimentary tract hemorrhage, active fundus hemorrhage, etc.)
  • Has a myocardial infarction, angina pectoris, or cerebral infarction within the latest 3 months
  • Congestive heart failure
  • Pregnant, potentially pregnant, or lactating woman
  • Severe hepatic inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range)
  • Serum creatinine level is 1.5 times higher than the upper limit of the normal value range
  • Persistent or hardly controlled hypertension (such as malignant hypertension, SBP≥170 mmHg and/ or DBP≥100 mmHg)
  • Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
  • Has a medical history of cardiac syncope or primary syncope
  • Has condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.), or for man QT interval>450msec, for woman QT interval>470msec
  • Has severe complication (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
  • Register other clinical trials within the latest 3 months
  • Other conditions that would be excluded from this study according to doctors'judgment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Universuty First Hospital

    Beijng, Beijing Municipality

Other trials in China

About this study

Official title: A Randomized, Control, Parallel, Open Label, Multi-centre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy

The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.

Read the detailed description

The objectives of this study is:

  1. To evaluate the efficacy of Probucol on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival).
  2. To evaluate the efficacy of Cliostazol and Probucol in combination on deferring nephropathy development of the patients with diabetic nephropathy
  3. To evaluate the efficacy of Cilostazol and Probucol in combination on atherosclerosis related biomarkers change. Atherosclerosis related biomarkers include:(a)Endothelium parameter: ICAM-1, vWF, VCAM-1,and McP-1. (b)Finolysis parameter: TM. (c)Inflammation parameter: Hs-CRP; IL-6. (d)Oxidation parameter: Ox-LDL, 8-OHdG. (e)Lipid parameter: TC, LDL-C, HDL-C, TG.
  4. To evaluate the efficacy of Cilostazol and Probucol in combination on the progress of carotid intima-media thickness (IMT) on patients with diabetic nephropathy.
  5. To evaluate the safety of Cilostazol and Probucol in combination on the patients with diabetic nephropathy.
Being tested
Probucol, Probucol and Cilostazol
Medical subject headings
Diabetic Nephropathies

What participants receive

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

  • ProbucolDrug

    250mg,Bid

  • Probucol and CilostazolDrug

    50-100mg,Bid

Study groups in NCT01252056
Study groupRoleWhat they receive
ControlNo interventionNot described
ProbucolActive comparatorProbucol treatment
Receives: Drug: Probucol
CombinationActive comparatorProbucol and Cilostazol
Receives: Drug: Probucol and Cilostazol

What is being measured

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

  1. nephropathy development

    After 96-week treatment, compare the efficacy between Probucol group and group control group on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival)

    Measured: 96W

Secondary outcomes (4)

  1. IMT

    After 48-week and 96-week treatment, compare the change value of IMT from the baseline among 3 modality groups.

    Measured: 48 and 96W

  2. Atherosclerosis related biomarkers

    After 12-week, 48-week and 96-week treatment, compare the change value of atherosclerosis related biomarkers from the baseline among 3 modality groups

    Measured: 48 and 96W

  3. Nephropathy development

    1. After 48-week and 96-week treatment, compare the efficacy among 3 modality groups on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival)

    Measured: 48 and 96W

  4. Adverse events

    Incidence of adverse events, clinically relevant abnormal laboratory results before and after treatment (including hemotology, biochemistry, routine urine analysis and glycosylated hemoglobin), abnormal findings of vital sign, physical examination, and 12-lead ECG results

    Measured: 96W

Timeline

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

  1. First posted2 Dec 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252056
Sponsor's protocol ID
260-09-805-01
Status last verified
May 2013
First submitted
21 Apr 2010
Last updated
8 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PubMed 35224730

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Probucol and Probucol and Cilostazol in people with Diabetic Nephropathy, run by Otsuka Beijing Research Institute at 1 site in China.

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 7 inclusion and 19 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 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

nephropathy development (time frame: 96W). 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 NCT01252056, 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 8 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in