Idiopathic steroid-sensitive nephrotic syndrome
Conditions
Brief summary
Time from randomization to first relapse of nephrotic syndrome (non-inferiority hypothesis).
Detailed description
Time from randomization to first relapse of nephrotic syndrome (superiority hypothesis)., Percentage of nephrotic syndrome relapse within 24 months., Cumulative dose of glucocorticoids administered within 24 months of randomization., Absolute values and differences from the entry assessment in the number of points obtained in the EQ-index (EQ-index) and analog scale (EQ-VAS) according to the EQ-5D-5L questionnaire at 24 months after randomization., Severe adverse event rate., Rate of adverse events of special interest.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to first relapse of nephrotic syndrome (non-inferiority hypothesis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to first relapse of nephrotic syndrome (superiority hypothesis)., Percentage of nephrotic syndrome relapse within 24 months., Cumulative dose of glucocorticoids administered within 24 months of randomization., Absolute values and differences from the entry assessment in the number of points obtained in the EQ-index (EQ-index) and analog scale (EQ-VAS) according to the EQ-5D-5L questionnaire at 24 months after randomization., Severe adverse event rate., Rate of adverse events of special interest. | — |
Countries
Poland