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The effect of cilostazol on proteinuria in diabetic nephropathy (randomized, comparative, multi-center study)

A prospective, randomized, double-blind placebo-controlled, multi-center studies on the effect of cilostazol on mild to moderate proteinuria in diabetic nephropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15007080
Enrollment
Unknown
Registered
2015-09-10
Start date
2014-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Interventions

1:Valrtan80mg/d
2:cilostazol100mg/d combined with valrtan 80mg/d

Sponsors

Nephrology Department, Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70yr, male or female; (2) Being diagnosed as DM for more than 5 years or combined with diabetic retinopathy. For those who it is difficult to exclude other kind of kindey disease, kindey biopsy will be needed; (3) Glycated hemoglobin(HbA1c) GA between 8.5% 24%, those stable for 8-12 weeks; (4) Persistent proteinuria: In 4 weeks, for 2 continuos test, urinary albumin to creatinine ratio (UACR) 3.5-116mg/mol 8hr urine albumin eliminate rate (UAE) 20-670ug/min. 24hr urinary protein excretion rate 40 ml/min; (6) For those with normal blood pressure, tolic blood pressure should>=100mmHg. for those with hypertesion, blood pressure should be control to less than 140/90mmHg in recent 3 months). Anti-hypertesion medicine that could be used: CCB, antidiuretic, beta-blocker or alpha-adrenergic blocking agent; (7) TG<4.5mmol/l, LDL<2.6mmol/L, CHO<4.5mmol/L; (8) No contraindications for ARB drugs.

Exclusion criteria

Exclusion criteria: 1. Allergic to cilostazol or valrtan; 2. Women in gestational lactational period; 3. Subjest with mental illness or malignant neoplasm; 4. Having major surgery in recent 6 months; 5. Having hemorrhage disease, like active peptic ulcer disease, cerebral hemorrhage, or severe aeimia; 6. Taking anticoagulant or anti-platelet drugs; 7. Severe heart failure (NYHAIII~IV); 8. Severe ventricular arrhythmia; 9. Having acute myocardial infart,angina pectoris or cerebral infartion in recent 1 month; 10. Obvious abnormal results of biochemical tests, eg liver function (result of ALT or AST is higher than 2 times of normal range); 11. Hypertension with SBP >=170mmHg or DBP>=100mmHg, is resistant to anti-hypertension medicine); 12. Untreated hyperlipemia (TG>4.5mmol/l, LDL>2.6mmol/L, CHO>4.5mmol/L); 13. Being enrolled to other clinical study in recent 3 months.

Design outcomes

Primary

MeasureTime frame
Urine albumin-to-creatinine ratio;

Countries

China

Contacts

Public ContactZheng Falei
zhengfl46@vip.sina.com+86 13520208758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026