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To evaluate the efficacy of different courses of beraprost sodium for diabetic proteinuria from a single-center, randomized, open clinical study

To evaluate the efficacy of different courses of beraprost sodium for diabetic proteinuria from a single-center, randomized, open clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035794
Enrollment
Unknown
Registered
2020-08-17
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Diabetic nephropathy

Interventions

short course group:Take beprost sodium for 12 weeks
long course group:Take beprost sodium for 24 weeks

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the 1999 WHO diagnostic criteria for type 2 diabetes; 2) "Mogenson stage albuminuria (UMA) >30 mg / 24 h; MDRD method for estimating glomerular filtration rate (eGFR) > 60 ml·min-1· 1.73 m_2; Or chronic arterial occlusive disease caused by ulcers, intermittent claudication, pain and cold symptoms 3) Hemoglobin a1c < 7.5%; 4) Aged 18-75 years.

Exclusion criteria

Exclusion criteria: 1)Allergic to beprost sodium; 2) Subjects with severe or coagulation disorders or subjects with bloody diseases within 6 months prior to the visit or subjects unable to tolerate anti-platelet drugs are screened. 3) Systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg at the time of interview and whose blood pressure was still higher than 170/100mmhg after two weeks of routine antihypertensive treatment. 4) Subjects with acute complications of diabetes (such as diabetic ketoacidosis and hyperosmotic state) within 3 months before the visit. 5) Suffered from major or severe diseases, such as cardiovascular and cerebrovascular events, malignant tumors, or had a history of mental illness 6) Pregnancy or lactation. 7) Urinary tract infection, urinary calculi, vaginitis or prostatitis, and the use of nephrotoxic drugs and other factors affecting urinary albumin excretion and detection.

Design outcomes

Primary

MeasureTime frame
Urine protein;

Secondary

MeasureTime frame
Glomerular filtration rate;Incidence of adverse events;

Countries

China

Contacts

Public ContactXiaopei Cao

The First Affiliated Hospital, Sun Yat-Sen University

caoxp@mail.sysu.edu.cn+86 13802503792

Outcome results

None listed

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