The MEMORINEPH study: Memory B cell level-based tailored treatment with Rixathon in children with complicated forms of steroid-sensitive Nephrotic syndrome

Conditions

Complicated forms of idiopathic steroid-sensitive nephrotic syndrome (SSNS)

Brief summary

Evaluation of the number of RTX re-infusions comparing the two therapeutic regimens based on flow cytometry assessment of total B cell reconstitution (Arm A) or memory (Arm B) during a 24-month follow-up

Detailed description

Assessment during a 24-month follow-up of: • The number of relapses (defined as the reappearance of massive proteinuria (>40 mg/m²/h in children or urine protein/creatinine ratio > 2 g/g) or a positive urine dipstick (≥3+ for 3 days or positive for 7 days), with or without edema); • The number of hospitalization days; • The number of severe infections (defined as infections requiring hospitalization); • The time to the first relapse or a positive urine dipstick, Exploratory endpoints: Evaluation using immunoturbidimetry and ELISA tests of serum levels of total immunoglobulins IgG, IgM, and IgA, as well as antibody titers specific to tetanus and HBV induced by vaccination. • Assessment of the incidence of prolonged hypogammaglobulinemia (defined as IgG levels < age-specific normal range) and/or severe hypogammaglobulinemia (IgG < 250 mg/dl), with potential need for the introduction of replacement therapy with IgG.

Related papers

No related papers found yet.

Interventions

DRUGRixathon 500 mg concentrate for solution for infusion

DRUGRixathon 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Evaluation of the number of RTX re-infusions comparing the two therapeutic regimens based on flow cytometry assessment of total B cell reconstitution (Arm A) or memory (Arm B) during a 24-month follow-up	—

Secondary

Measure	Time frame
Assessment during a 24-month follow-up of: • The number of relapses (defined as the reappearance of massive proteinuria (>40 mg/m²/h in children or urine protein/creatinine ratio > 2 g/g) or a positive urine dipstick (≥3+ for 3 days or positive for 7 days), with or without edema); • The number of hospitalization days; • The number of severe infections (defined as infections requiring hospitalization); • The time to the first relapse or a positive urine dipstick, Exploratory endpoints: Evaluation using immunoturbidimetry and ELISA tests of serum levels of total immunoglobulins IgG, IgM, and IgA, as well as antibody titers specific to tetanus and HBV induced by vaccination. • Assessment of the incidence of prolonged hypogammaglobulinemia (defined as IgG levels < age-specific normal range) and/or severe hypogammaglobulinemia (IgG < 250 mg/dl), with potential need for the introduction of replacement therapy with IgG.	—

Measure

Time frame

Assessment during a 24-month follow-up of: • The number of relapses (defined as the reappearance of massive proteinuria (>40 mg/m²/h in children or urine protein/creatinine ratio > 2 g/g) or a positive urine dipstick (≥3+ for 3 days or positive for 7 days), with or without edema); • The number of hospitalization days; • The number of severe infections (defined as infections requiring hospitalization); • The time to the first relapse or a positive urine dipstick, Exploratory endpoints: Evaluation using immunoturbidimetry and ELISA tests of serum levels of total immunoglobulins IgG, IgM, and IgA, as well as antibody titers specific to tetanus and HBV induced by vaccination. • Assessment of the incidence of prolonged hypogammaglobulinemia (defined as IgG levels < age-specific normal range) and/or severe hypogammaglobulinemia (IgG < 250 mg/dl), with potential need for the introduction of replacement therapy with IgG.

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Countries

Italy

Outcome results

None listed