Randomization and treatment protocol
thrombosis, nephrotic syndrome
THROMBOSIS, GROUP B, ADVERSE EVENTS, NEPHROTIC SYNDROME, REMISSION
After enrollment, patients were randomly assigned to three groups in a 1:1:1 ratio, and an observer-blinded approach was followed. Randomization was performed using a random number table with a central computerized system. Group A was administered an oral dose of 100 mg of indobufen twice daily. Group B was administered an oral dose of 200 mg of indobufen twice daily. Group C received 3 mg of warfarin orally once a day. Dose adjustment was based on the PT. The international normalized ratio (INR) was maintained between 1.5 and 3.0.Patients were followed-up for 12 weeks, and study visits occurred at baseline and at weeks 1, 4, 8, and 12. Patients or researchers had the option of discontinuing treatment early because of unacceptable serious adverse events (SAEs), any change in the patient’s condition that justified discontinuation (decided by the researcher; included the requirement for any drug that treats thrombosis, which was an exclusion criterion), withdrawal of consent (decided by the patient), and complete remission of nephrotic syndrome (24-h urinary protein < 0.3 g, serum albumin > 35 g/L).