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

NCT ID: NCT01252056

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-12-31

Brief Summary

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

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.

Conditions

Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Probucol

Probucol treatment

Group Type: ACTIVE_COMPARATOR

Probucol

Intervention Type: DRUG

250mg,Bid

Combination

Probucol and Cilostazol

Group Type: ACTIVE_COMPARATOR

Probucol and Cilostazol

Intervention Type: DRUG

50-100mg,Bid

Interventions

Probucol

250mg,Bid

Intervention Type: DRUG

Probucol and Cilostazol

50-100mg,Bid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaohui Guo

Role: PRINCIPAL_INVESTIGATOR

Beijing University First Hospital

Locations

Beijing Universuty First Hospital

Beijng, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35224730 (View on PubMed)

Other Identifiers

260-09-805-01

Identifier Type: -

Identifier Source: org_study_id