Anti-platelet therapy for prevention of diabetic nephropathy

Phase 2

• Conditions: diabetic nephropathy

• Registration Number: JPRN-UMIN000007718
• Lead Sponsor: ational Hospital Organization Headquarters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-10
• Study Completion: 2013-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine albumin creatinine ratio (ACR) (a geometric mean of 2nd continuation)

Secondary Outcome Measures

Name	Time	Method
<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)