Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Complications Drug: Cilostazol Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
Active Comparator: Cilostazol
Cilostazol 100 mg twice daily
Drug: Cilostazol
Cilostazol 100 mg twice daily
Other Name: Pletaal

Placebo Comparator: Placebo Drug: Placebo
1 tablet twice daily




Primary Outcome Measures :
  1. Doubling of serum creatinine level [ Time Frame: 1 year ]
  2. 50% reduction in GFR (estimated by MDRD equation) [ Time Frame: 1 year ]
  3. GFR less than 15 ml/min/1.73m2 [ Time Frame: 1 year ]
  4. Need for dialysis [ Time Frame: 1 year ]
  5. Death related to renal causes [ Time Frame: 1 year ]
  6. Fatal or severe bleeding [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272831


Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Peter C Tong, PhD, MBBS Chinese University of Hong Kong
Layout table for additonal information
Responsible Party: Dr Peter CY Tong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00272831    
Other Study ID Numbers: PWH 2005-146-T
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 22, 2009
Last Verified: May 2009
Keywords provided by Chinese University of Hong Kong:
Diabetic nephropathy
Macroalbuminuria
Pletaal
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors