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BOOSTER – Multicenter, Open Label, Randomized Control Phase III Trial Comparing the Efficacy and Safety of Two Rituximab Regimens in Maintenance Therapy for Relapsing Nephrotic Syndrome Due to Podocytopathies in Adults.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509755-13-00
Acronym
2023-002
Enrollment
70
Registered
2025-02-10
Start date
2025-04-28
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic steroid-sensitive nephrotic syndrome

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

DRUGRITUXIMAB

Sponsors

Medical University Of Lodz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time from randomization to first relapse of nephrotic syndrome (non-inferiority hypothesis).

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026