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The Use of Cilostazol in Patients With Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00272831
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : May 22, 2009
Sponsor:
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE January 5, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date May 22, 2009
Study Start Date  ICMJE December 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Doubling of serum creatinine level [ Time Frame: 1 year ]
  • 50% reduction in GFR (estimated by MDRD equation) [ Time Frame: 1 year ]
  • GFR less than 15 ml/min/1.73m2 [ Time Frame: 1 year ]
  • Need for dialysis [ Time Frame: 1 year ]
  • Death related to renal causes [ Time Frame: 1 year ]
  • Fatal or severe bleeding [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
  • Primary endpoints:
  • 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
  • Primary safety endpoint:
  • Fatal or severe bleeding
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • 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 ]
  • Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
  • Other endpoints:
  •  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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Cilostazol in Patients With Diabetic Nephropathy
Official Title  ICMJE A Randomised, Double-Blind, Placebo-Controlled Study of Cilostazol 100 mg Twice Daily in the Treatment of Diabetic Nephropathy in Hong Kong Chinese
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Diabetes Complications
Intervention  ICMJE
  • Drug: Cilostazol
    Cilostazol 100 mg twice daily
    Other Name: Pletaal
  • Drug: Placebo
    1 tablet twice daily
Study Arms  ICMJE
  • Active Comparator: Cilostazol
    Cilostazol 100 mg twice daily
    Intervention: Drug: Cilostazol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2009)
62
Original Enrollment  ICMJE
 (submitted: January 5, 2006)
60
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients aged between 20 and 70 years
  2. Patients with Type 2 diabetic mellitus
  3. 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
  4. 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)
  5. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT00272831
Other Study ID Numbers  ICMJE PWH 2005-146-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Peter CY Tong, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter C Tong, PhD, MBBS Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP