- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00272831
The Use of Cilostazol in Patients With Diabetic Nephropathy
A Randomised, Double-Blind, Placebo-Controlled Study of Cilostazol 100 mg Twice Daily in the Treatment of Diabetic Nephropathy in Hong Kong Chinese
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
|
1 comprimé deux fois par jour
|
Comparateur actif: Cilostazol
Cilostazol 100 mg twice daily
|
Cilostazol 100 mg deux fois par jour
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Doubling of serum creatinine level
Délai: 1 year
|
1 year
|
50% reduction in GFR (estimated by MDRD equation)
Délai: 1 year
|
1 year
|
GFR less than 15 ml/min/1.73m2
Délai: 1 year
|
1 year
|
Need for dialysis
Délai: 1 year
|
1 year
|
Death related to renal causes
Délai: 1 year
|
1 year
|
Fatal or severe bleeding
Délai: 1 year
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia) requiring hospital admissions, lower extremity amputation)
Délai: 1 year
|
1 year
|
Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
Délai: 1 year
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Peter C Tong, PhD, MBBS, Chinese University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies urologiques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Maladies rénales
- Néphropathies diabétiques
- Complications du diabète
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents vasodilatateurs
- Agents autonomes
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Inhibiteurs de l'agrégation plaquettaire
- Agents neuroprotecteurs
- Agents protecteurs
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Inhibiteurs de la phosphodiestérase
- Inhibiteurs de la phosphodiestérase 3
- Cilostazol
Autres numéros d'identification d'étude
- PWH 2005-146-T
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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