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A Randomized, Single-Blind, Positive-controlled, Clinical Study to Evaluate the Efficacy and Safety of Prostaglandin Preparations Compared With Irbesartan in the Treatment of Type 2 Diabetic Patients With Overt Proteinuria

and Safety of Prostaglandin Preparations Compared With Irbesartan in the Treatment of Type 2 Diabetic Patients With Overt Proteinuria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002458
Enrollment
Unknown
Registered
2012-08-16
Start date
2012-09-01
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

A, B1, B2:Step 1: Group A: Irbesartan 300mg Qd Po
Group B: Beraprost Sodium Tablet 40ug Tid Po +Alprostadil Fat Emulsiom Injection+placebo. Step 2: Group B1 Beraprost Sodium Tablet 40ug Tid Po +Alprostadil Fat Emulsiom Injection
Group B2 oral Beraprost Sodium Tablet 40ug Tid Po + placebo

Sponsors

Dept. of Endocrinology & Metabolism,Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 30 - 70 years; 2. A documented diagnosis of type 2 diabetes mellitus > 1year (WHO 1999); 3. Diabetic nephropathy with overt proteinuria: morning urine ACR >=300mg/g; sCr 88 - 265 umol/L; 4. With or without hypertension (>=130/80 mmHg): ACEIs and ARBs must be discontinued for at least 10-day prior to cellection of the first urine sample.

Exclusion criteria

Exclusion criteria: 1. T2DM patients 10%; 3. Patients with diabetic acute complications, or sever diabetic chronic complications, i.e retinal hemorrhage, sCr>= 266umol/L, diabetic feet with infection; 4. Patients with hemorrhagic tendency, or active hemorrhage within 1 week; 5. Clinically significant heart disease, stroke, renal artery stenosis, hepatic dysfunction; 6. Electrolyte imbalance, serum potassium level >5.5mmol/L; 7. Absence of diabetic retinopathy; 8. Low or rapidly decreasing GFR; 9. Rapidly increasing proteinuria or nephrotic syndrome; 10. Uncontrolled hypertension >=160/100mmHg; 11. Presence of active urinary sediment or urinary tract infection; 12. Signs or symptoms of other systemic disease; 13. >30% reduction in GFR within 2-3 months after initiation of an ACE inhibitor or ARB; 14. Known hypersensitivity to any component of the study medications.

Design outcomes

Primary

MeasureTime frame
24h urine protein excretion;eGFR;—

Secondary

MeasureTime frame
24h urine albumin excretion;morning urine albumin- creatinine ratio;serum creatinin;—

Countries

China

Contacts

Public ContactXue Yaoming
yaomingxue@126.com+86 13926066999

Outcome results

None listed

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