The Use of Cilostazol in Patients With Diabetic Nephropathy

NCT00272831 | Completed Phase 4

• 1 other identifier: PWH 2005-146-T
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Keywords

Diabetic nephropathy; Macroalbuminuria; Pletaal

Outcome Measures

Primary Outcomes (6)

• Doubling of serum creatinine level

  1 year

• 50% reduction in GFR (estimated by MDRD equation)

  1 year

• GFR less than 15 ml/min/1.73m2

  1 year

• Need for dialysis

  1 year

• Death related to renal causes

  1 year

• Fatal or severe bleeding

  1 year

Secondary Outcomes (2)

• Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia) requiring hospital admissions, lower extremity amputation)

  1 year

• Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department

  1 year

Study Arms (2)

Cilostazol

ACTIVE COMPARATOR

Cilostazol 100 mg twice daily

Drug: Cilostazol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cilostazol DRUG

Cilostazol 100 mg twice daily

Also known as: Pletaal

Cilostazol

Placebo DRUG

1 tablet twice daily

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications; Diabetic Nephropathies

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Peter C Tong, PhD, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 22, 2009

Record last verified: 2009-05