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Indobufen prevents thrombosis in patients with nephrotic syndrome: efficacy and safety of randomized, open label, parallel controlled trial

Indobufen prevents thrombosis in patients with nephrotic syndrome: efficacy and safety of randomized, open label, parallel controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013428
Enrollment
Unknown
Registered
2017-11-17
Start date
2017-12-01
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Nephrotic syndrome

Interventions

Indobufen low dose group:Indobufen:100 mg, bid
Warfarin:Warfarin starting dose:3mg/qd,INR:2.0-3.0
Indobufen high dose group:Indobufen:200 mg, bid

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age> 18 years old; 2. Diagnosis of primary or secondary NS, Ccr> 80ml/min; 3. Patients diagnosed with hypercoagulability or who have a high risk of DVT, requiring indobufen or warfarin to prevent anticoagulation; 4. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Previous patients with an allergy to indobufen or warfarin; 2. Patients diagnosed with embolism by B-mode ultrasound, CT, magnetic resonance tomography (MR), and pulmonary ventilation perfusion scintigraphy, or unexplained D-dimer doubling, up to 2 times the upper limit of the reference value; 3. Coagulation disorders exist; 4. Patients with uncontrolled hypertension have diastolic blood pressure> 100 mmHg; 5. Patients with severe hepatic and renal impairment; 6. Patients with bleeding risk, active ulcers or history of gastrointestinal bleeding; 7. are taking other drugs that affect the clinical trial outcome, such as glipizide; 8. Pregnant women; 9. unable to complete the follow-up due to their own conditions and other reasons; 10. merged with cancer, severe heart failure, etc.; 11. Participate in any drug test within the first 3 months of enrollment; 12. Any other diseases that the researchers think are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
D-dimer;Color Doppler ultrasound (lower extremity ultrasound, renal color Doppler ultrasound);Thromboembolic event rate;

Secondary

MeasureTime frame
Blood clotting four;INR;Incidence of side effects(The incidence of side effects at 1 month, 2 months, and 3 months was recorded, including headache, nausea and vomiting, rash, diarrhea, and elevated liver enzymes.);Bleeding events and incidence(Record the patient's 1 month, 2 months, 3 months bleeding events and incidence, including: gastrointestinal bleeding, nose bleeding, subcutaneous hemorrhage, fundus hemorrhage, non-glomerular causes of hematuria, etc.);

Countries

China

Contacts

Public ContactYiwen Li

Zhejiang Provincial People's Hospital

Yiwen1962@163.com+86 13456775925

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026