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The Use of Cilostazol in Patients With Diabetic Nephropathy

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Complications

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetic nephropathy, Macroalbuminuria, Pletaal

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients aged between 20 and 70 years Patients with Type 2 diabetic mellitus A fasting urinary albumin/creatinine ratio greater than or equal to 30 mg/mmol or 24 hour urinary albumin excretion greater than or equal to 300 mg/day in two urine collections during the baseline period Two consecutive serum creatinine levels during baseline period which meet the following requirements: Women: between 80 umol/l and 250 umol/l (inclusive) Men: between 105 umol/l and 250 umol/l (inclusive) Written informed consent Exclusion Criteria: Pregnancy Known allergy to cilostazol or aspirin Congestive heart failure (NYHA class III to IV) Severe liver impairment (greater than or equal to 3 times ULN of ALT) Serum potassium levels greater than or equal to 5.5 mmol/l on 2 consecutive specimens

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Cilostazol

    Placebo

    Arm Description

    Cilostazol 100 mg twice daily

    Outcomes

    Primary Outcome Measures

    Doubling of serum creatinine level
    50% reduction in GFR (estimated by MDRD equation)
    GFR less than 15 ml/min/1.73m2
    Need for dialysis
    Death related to renal causes
    Fatal or severe bleeding

    Secondary Outcome Measures

    Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia) requiring hospital admissions, lower extremity amputation)
    Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department

    Full Information

    First Posted
    January 5, 2006
    Last Updated
    May 21, 2009
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00272831
    Brief Title
    The Use of Cilostazol in Patients With Diabetic Nephropathy
    Official Title
    A Randomised, Double-Blind, Placebo-Controlled Study of Cilostazol 100 mg Twice Daily in the Treatment of Diabetic Nephropathy in Hong Kong Chinese
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with type 2 diabetes have a long duration of disease for the development of complications. Among all complications, microangiopathic complications are major causes of mortality and morbidity in diabetic patients. In Asia, patients with type 2 diabetes are particularly susceptible to the development of kidney disease. Patients with diabetic kidney disease have more adverse metabolic profiles and increased risk of having other complications such as blindness, stroke, heart attack and nerve damage than those without. Despite receiving the best of care, the combined event rate of death, cardiovascular disease and end stage kidney disease in diabetic patients with renal impairment remained as high as 10% per year. Cilostazol reduces platelet aggregation and prevents formation of blood clots. Furthermore, cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels. In this randomized placebo-controlled, double-blinded study, the investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment. Sixty patients will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months. The effect of Cilostazol on the progression of diabetic nephropathy, as defined by rates of decline in glomerular filtration rate, serum creatinine and urinary albumin excretion rate will be measured. The results will provide additional insight on the management of diabetic kidney disease which is prevalent among Chinese diabetic patients in Hong Kong.
    Detailed Description
    Hypothesis: Cilostazol reduces the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment secondary to diabetic nephropathy. Objectives: To assess the suppressive effect of Cilostazol on the progression of diabetic nephropathy, as defined by rates of decline in glomerular filtration rate, serum creatinine and urinary albumin excretion rate. The rising prevalence of diabetes in Asia imposes a heavy burden on the health care system. Given the increasingly early onset of disease, patients with type 2 diabetes have long duration of disease for the development of complications. Among all complications, microangiopathic complications are major causes of mortality and morbidity in diabetic patients. In Asia, patients with type 2 diabetes are particularly susceptible to the development of nephropathy. Among dialysis patients, the primary disease is diabetic nephropathy in about 40 to 50 % of patients. Despite the inhibition of the renin angiotensin system using either ACE inhibitor or AII receptor blocker (ARB) as well as introduction of tight glycaemic and blood pressure control, the prevalence of diabetic nephropathy remains high. More importantly, patients with nephropathy have more adverse metabolic profiles and increased risk of having other complications such as retinopathy, macrovascular diseases and neuropathy than those without. Indeed, according to the RENAAL Study, despite receiving the best of care, the combined event rate of death, cardiovascular disease and end stage renal disease in diabetic patients with renal impairment remained as high as 10% per year. Cilostazol exerts antiplatelet, antithrombotic and vasodilating effects by inhibiting phosphodiesterase type 3 in platelets and vascular smooth muscle cells. Furthermore, cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels. In Japanese patients with type 2 diabetes, cilostazol therapy was associated with regression of carotid intimal media thickness and could prevent the onset of silent brain infarction. On the other hand, abnormal metabolism of prostaglandins in renal glomeruli has been postulated to modulate renal haemodynamics. Elevated levels of platelet-derived microparticles and soluble adhesion molecules may further contribute to the development of diabetic nephropathy. Cilostazol treatment had been shown to reduce serum levels of PMP, activated platelet subsets, soluble adhesion molecules and urinary excretion of thromboxane B2 in patients with type 2 diabetes. These changes were accompanied by a reduction in urinary albumin excretion and an increase in creatinine clearance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Diabetes Complications
    Keywords
    Diabetic nephropathy, Macroalbuminuria, Pletaal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cilostazol
    Arm Type
    Active Comparator
    Arm Description
    Cilostazol 100 mg twice daily
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Cilostazol
    Other Intervention Name(s)
    Pletaal
    Intervention Description
    Cilostazol 100 mg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    1 tablet twice daily
    Primary Outcome Measure Information:
    Title
    Doubling of serum creatinine level
    Time Frame
    1 year
    Title
    50% reduction in GFR (estimated by MDRD equation)
    Time Frame
    1 year
    Title
    GFR less than 15 ml/min/1.73m2
    Time Frame
    1 year
    Title
    Need for dialysis
    Time Frame
    1 year
    Title
    Death related to renal causes
    Time Frame
    1 year
    Title
    Fatal or severe bleeding
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia) requiring hospital admissions, lower extremity amputation)
    Time Frame
    1 year
    Title
    Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients aged between 20 and 70 years Patients with Type 2 diabetic mellitus A fasting urinary albumin/creatinine ratio greater than or equal to 30 mg/mmol or 24 hour urinary albumin excretion greater than or equal to 300 mg/day in two urine collections during the baseline period Two consecutive serum creatinine levels during baseline period which meet the following requirements: Women: between 80 umol/l and 250 umol/l (inclusive) Men: between 105 umol/l and 250 umol/l (inclusive) Written informed consent Exclusion Criteria: Pregnancy Known allergy to cilostazol or aspirin Congestive heart failure (NYHA class III to IV) Severe liver impairment (greater than or equal to 3 times ULN of ALT) Serum potassium levels greater than or equal to 5.5 mmol/l on 2 consecutive specimens
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter C Tong, PhD, MBBS
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Use of Cilostazol in Patients With Diabetic Nephropathy

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