Trial · NCT03298698
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete remission | 8 weeks | The proportion of patients reaching complete remission defined as proteinuria \<0.3 g/day or \< 300 mg/g |
| Secondary | Partial remission | 8 weeks | The proportion of patients reaching partial remission defined as proteinuria \< 3.5 g/24 h or \< 3.5 g/g and 50% lower than baseline proteinuria |
| Secondary | Late complete or partial remission | 2-12 months | The proportion of patients reaching complete remission defined as proteinuria \<0.3 g/day or \< 300 mg/g or The proportion of patients reaching partial remission defined as proteinuria \< 3.5 g/24 h or \< 3500 mg/g and 50% lower than baseline proteinuria |
| Secondary | Time to remission | 12 months | Time between start of treatment and reaching partial or complete remission |
| Secondary | Time to relapse | 12 months | The time between partial or complete remission and relapse (defined as urinary protein excretion to ≥3.5 g/24 h or ≥3.5 g/g creatinine |
| Secondary | Proportion of patients with a relapse | 12 months | The proportion of patients with relapse (defined as urinary protein excretion to ≥3.5 g/24 h or ≥3.5 g/g creatinine in patients who had at least attained a partial remission and the time to relapse |
| Secondary | Proportion of patients treated with additional immunosuppressive drugs | 12 months | Proportion of patients treated with immunosuppressive drugs other than the assigned treatment with rituximab or prednisolone |
| Secondary | General health assessment | at 2, 6, 9 and 12 months | Difference in general health measured by RAND-36 |
| Secondary | Quality of life measured with TAAQOL | at 2, 6, 9 and 12 months | Difference in quality of life measured with TNO-academisch Ziekenhuis Leiden Questionnaire for Adult's Health-Difference in Quality of Life |
| Secondary | Proportion of patients with adverse events | at 2 and 12 months | The proportion of patients with adverse events. Adverse events graded according to Common Terminology Criteria For Adverse Events (NCI-CTCAE v4.03) |
| Secondary | Cost-effectiveness analysis | at 2, 6, 9 and 12 months | Cost-effectiveness will be calculated by dividing the difference in costs by the difference in effectiveness (based on the number of patients in remission) derived from the two groups. The resulting cost-effectiveness ratio will be expressed as costs per one more patient in remission |
| Secondary | Cost-utility analysis | at 2, 6, 9 and 12 months | Cost-utility analysis will be calculated by dividing the difference in costs by the difference in Quality Adjusted Life Years (QALY's). QALY's will be derived from the EuroQol-5d-5L questionnaire. |
| Secondary | Difference in kidney function | at 2 and 12 months | Difference in creatinine clearance and estimated glomerular filtration rate |
| Secondary | Proportion of patients with an increase of baseline serum creatinine ≥ 50% | at 2 and 12 months | The percentage of patients with an increase \> 50% of serum creatinine from baseline. |
| Secondary | Benefit-risk ratio 1 | at 2 and 12 months | Difference in the percentage of remissions (benefit) divided by the difference in adverse events grade 3 or 4, including Serious Adverse Events and Suspected Unexpected Serious Adverse Reaction (risk) |
| Secondary | Benefit-risk ratio 2 | at 2 and 12 months | Difference in the percentage of remissions (benefit) divided by the difference in the total number of adverse events (risk) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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