A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome

Conditions

Childhood Idiopathic Nephrotic Syndrome

Brief summary

1. Percentage of Participants with Sustained Complete Remission at 1 year

Detailed description

1. Overall relapse-free survival (RFS), 2. Probability of RFS at Week 52, 3. Cumulative corticosteroid dose, 4. Number of relapses, 5. Proportion of participants experiencing edema associated relapse during the 52-week treatment period, 6. Proportion of patients with sustained complete remission at Week 76, 7. Mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue scale total score from baseline to Week 52, 8. Mean change in “Physical Functioning” domain of PedsQL-Quality of Life Inventory from baseline to Week 52, 9. Mean change in CureGN Edema Scale from baseline to Week 52, 10. Incidence, nature, and severity of adverse events, with severity determined according to AE intensity (mild, moderate, severe, life-threatening) and NCI CTCAE grading if applicable from baseline to Week 52, 11. Incidence of laboratory or vital sign abnormalities from baseline to Week 52, 12. Serum concentrations of obinutuzumab at specified timepoints, 13. Proportion of participants achieving B-cell depletion (HSFC) at specified timepoints, 14. Total peripheral B cell and B cell subsets (e.g., memory B cells) counts and change from baseline at specified timepoints

Julien Hogan, Jie Ding, Larry A. Greenbaum, Małgorzata Mizerska-Wasiak, Kandai Nozu et al. (10 authors)

Nephrology Dialysis Transplantation2025-10-01

10.1093/ndt/gfaf116.1517

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCellCept 500 mg film-coated tablets

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

DRUGCellCept 1 g/5 ml powder for oral suspension

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
1. Percentage of Participants with Sustained Complete Remission at 1 year	—

Secondary

Measure	Time frame
1. Overall relapse-free survival (RFS), 2. Probability of RFS at Week 52, 3. Cumulative corticosteroid dose, 4. Number of relapses, 5. Proportion of participants experiencing edema associated relapse during the 52-week treatment period, 6. Proportion of patients with sustained complete remission at Week 76, 7. Mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue scale total score from baseline to Week 52, 8. Mean change in “Physical Functioning” domain of PedsQL-Quality of Life Inventory from baseline to Week 52, 9. Mean change in CureGN Edema Scale from baseline to Week 52, 10. Incidence, nature, and severity of adverse events, with severity determined according to AE intensity (mild, moderate, severe, life-threatening) and NCI CTCAE grading if applicable from baseline to Week 52, 11. Incidence of laboratory or vital sign abnormalities from baseline to Week 52, 12. Serum concentrations of obinutuzumab at specified timepoints, 13. Proportion of participants achiev	—

Measure

Time frame

1. Overall relapse-free survival (RFS), 2. Probability of RFS at Week 52, 3. Cumulative corticosteroid dose, 4. Number of relapses, 5. Proportion of participants experiencing edema associated relapse during the 52-week treatment period, 6. Proportion of patients with sustained complete remission at Week 76, 7. Mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue scale total score from baseline to Week 52, 8. Mean change in “Physical Functioning” domain of PedsQL-Quality of Life Inventory from baseline to Week 52, 9. Mean change in CureGN Edema Scale from baseline to Week 52, 10. Incidence, nature, and severity of adverse events, with severity determined according to AE intensity (mild, moderate, severe, life-threatening) and NCI CTCAE grading if applicable from baseline to Week 52, 11. Incidence of laboratory or vital sign abnormalities from baseline to Week 52, 12. Serum concentrations of obinutuzumab at specified timepoints, 13. Proportion of participants achiev

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Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed