diabetic nephropathy
Conditions
Interventions
OPC-13013 placebo: administration for 12 weeks
OPC-13013 100 mg: administration for 12 weeks
OPC-13013 200 mg: administration for 12 weeks
Sponsors
National Hospital Organization Headquarters
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes mellitus outpatients, no limitation of treatment. 2) Ranging in age from 20 to 75 years at informed consent. 3) Diabetic nephropathy, stage III (serum CRE < 2.5 mg/dl and ACR>300 mg/g CRE at visit 2) 4) HbA1c (NGSP) < 9.4% at visit 2. 5) Blood pressure < 160/100 mmHg at visit 2. 6) Patient administrated with renin-angiotensin system inhibitors for more than three months. During this trial, addition and change of renin-angiotensin system inhibitors are not permitted in principle. Kinds of other anti-hypertensive drug were not limited. 7) No limitation for administration of anti-platelets excepting dipyridamole. Dipyridamole should be stopped at the day more than 28 days before visit 3, or changed to other antiplatelets at informed consent. Patient treated with other antiplatelets must be administrated for more than 3 months and addition and change of them are not permitted during this trial.
Exclusion criteria
Exclusion criteria: 1) The patient who has hypersensitivity to cilostazol. 2) Contraindication of cilostazol (patients with bleeding and congestive heart failure). 3) The patient administrated cilostazol previously (since possibility to have an influence on the efficacy and the safety). 4) The patient administrated dipyridamole at informed consent and has difficulty for interruption. 5) Tachycardia (heart rate > 100/min) in ECG at visit 2. 6) Severe liver dysfunction (more than 3 times of the standard value upper limit of AST, ALT, &#61543;-GTP) an visit 2 7) Hb < 9g/dl at visit 2. 8) Pregnant or pregnantpossibility. 9) The patient who has malignancy or previous history of malignancy (however, patient, who is unnecessary of treatment, no recurrence, and become no recurrence during trial, can participate) 10) The patient who has previous history of bleeding, was under treatment of bleeding, or has active diabetic retinopathy. 11) The patient who has the following diseases at Visit2. Chronic urinary tract infection Neurogenic bladder Nephritis or suspect Renal disease excepting diabetic nephropathy (chronic glomerulonephritis, polycystic kidney disease, etc.) 12) The patient administrated CYP3A4 inhibitors (macrolide antibiotic, HIV protease inhibitor, azole antifungals, cimetidine, Diltiazem hydrochloride, etc) (since the pharmacodynamics of cilostazole in vivo will affect the evaluation of dose-reaction relationship) 13) The patient who had participated trials of other unrecognized pharmaceutical products or medical device in the past 30 days. 14) The patient judged to be inadequacy by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin creatinine ratio (ACR) (a geometric mean of 2nd continuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> eGFR, serum cystatin C, and serum high molecular weight adiponectin <Safety> (1) Influence to diabetes and diabetic nephropathy (significant increase of HbA1c, ACR and decrease of eGFR) (2)Comparison of adverse effects (containing change of laboratory data) | — |
Countries
Japan
Contacts
Public ContactNaoto Seki, M.D.
National Hospital Organization Chiba-higasi Hospital Clinical Research Center
Outcome results
None listed