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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. (B cell Depletion Therapy to Improve Outcomes of Relapsing STERoid-sensitive Podocytopathies in Adults – BOOSTER trial)
EU CTIS ID: 2023-509755-13-00
What this study is testing
To compare the efficacy of two Rituximab treatment regimens in terms of time to nephrotic syndrome recurrence (non-inferiority hypothesis).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent to participate in the study.
- Age of at least 18 years.
- Diagnosis of podocytopathy of the most likely primary (immune-mediated) nature, meeting all of the following criteria: a. Histopathological diagnosis of MCD (Minimal Change Disease) or FSGS (Focal Segmental Glomerulosclerosis)*; AND b. A history of good response to standard-dose glucocorticoids treatment - defined as complete remission of nephrotic syndrome within 16 weeks of treatment with prednisone at a dose of up to 1 mg/kg/day, max. 80 mg/day (or equivalent dose of another glucocorticoid) or up to 2mg/kg/48h, max. 120 mg (or equivalent dose of another glucocorticoid) preceded or not preceded by the administration of intravenous glucocorticoids; c. Excluded secondary causes of nephrotic syndrome. *It is acceptable to include a patient without or with a non-diagnostic biopsy result as long as criteria 3b and 3c are met and the disease course is typical of podocytopathy and the differential diagnosis does not support another diagnosis. Each case should be considered individually, in consultation with the Coordinating Investigator.
- A relapsing course of disease that meets all of the following criteria: a. At least 1 relapse of nephrotic syndrome in the history; b. Last relapse of nephrotic syndrome within 2 years prior to study inclusion that occurred during immunosuppressive therapy or within 6 months of its withdrawal.
- Ongoing immunosuppressive treatment to maintain remission after the last relapse lasting min. 2 weeks and max. 100 weeks (patients with SD (steroid-dependence)/FR (frequent relapses)) from achieving partial or complete remission.
- At the time of inclusion in the study, at least partial remission of disease with proteinuria < 1.0 g/day (or uPCR <1000 mg/g) achieved with treatment with glucocorticoids and/or glucocorticoids-sparing immunosuppressant.
You likely can't join if
- Probable or certain secondary cause of podocytopathy, including, but not limited to, chronic use of medications with a confirmed association with MCD (Minimal Change Disease) (e.g., lithium salts, interferon, non-steroidal anti-inflammatory drugs), paraneoplastic syndrome, podocyte protein mutations.
- Treatment with cyclophosphamide within 6 months prior to study inclusion.
- Treatment with rituximab within 18 months prior to study inclusion.
- Presence of any of the contraindications to the administration of rituximab (according to the SmPC): a. Hypersensitivity to the active substance or excipients; b. Hypersensitivity to mouse proteins; c. Active infection with a severe course; d. Severe immunodeficiency*; e. Pregnancy, breastfeeding, or refusal to use effective pregnancy prevention methods during the study (applies to women); f. Severe heart failure (NYHA class IV) or severe uncontrolled heart disease. g. Post-vaccination status with a live vaccine within 4 weeks prior to study inclusion. * Immunoglobulin G deficiency secondary to nephrotic syndrome, as well as immunoglobulin G deficiency with serum IgG levels >250 g/L without a history of severe infectious complications, should not be considered as an absolute exclusion criterion. Each case should be considered individually.
- A positive result on any of the following virology tests: a. Presence of anti-HIV antibodies; b. Presence of anti-HCV antibodies** and HCV RNA viremia; c. Presence of HBs antigen. If anti-HCV antibodies are found, the patient may be eligible for the study provided that HCV RNA viremia is absent.
- Glomerular filtration rate - eGFR less than 45 ml/min/1.73m2 according to the CKD-EPI 2021 formula.
See the full eligibility criteria
Who can join
- Informed consent to participate in the study.
- Age of at least 18 years.
- Diagnosis of podocytopathy of the most likely primary (immune-mediated) nature, meeting all of the following criteria: a. Histopathological diagnosis of MCD (Minimal Change Disease) or FSGS (Focal Segmental Glomerulosclerosis)*; AND b. A history of good response to standard-dose glucocorticoids treatment - defined as complete remission of nephrotic syndrome within 16 weeks of treatment with prednisone at a dose of up to 1 mg/kg/day, max. 80 mg/day (or equivalent dose of another glucocorticoid) or up to 2mg/kg/48h, max. 120 mg (or equivalent dose of another glucocorticoid) preceded or not preceded by the administration of intravenous glucocorticoids; c. Excluded secondary causes of nephrotic syndrome. *It is acceptable to include a patient without or with a non-diagnostic biopsy result as long as criteria 3b and 3c are met and the disease course is typical of podocytopathy and the differential diagnosis does not support another diagnosis. Each case should be considered individually, in consultation with the Coordinating Investigator.
- A relapsing course of disease that meets all of the following criteria: a. At least 1 relapse of nephrotic syndrome in the history; b. Last relapse of nephrotic syndrome within 2 years prior to study inclusion that occurred during immunosuppressive therapy or within 6 months of its withdrawal.
- Ongoing immunosuppressive treatment to maintain remission after the last relapse lasting min. 2 weeks and max. 100 weeks (patients with SD (steroid-dependence)/FR (frequent relapses)) from achieving partial or complete remission.
- At the time of inclusion in the study, at least partial remission of disease with proteinuria < 1.0 g/day (or uPCR <1000 mg/g) achieved with treatment with glucocorticoids and/or glucocorticoids-sparing immunosuppressant.
What rules you out
- Probable or certain secondary cause of podocytopathy, including, but not limited to, chronic use of medications with a confirmed association with MCD (Minimal Change Disease) (e.g., lithium salts, interferon, non-steroidal anti-inflammatory drugs), paraneoplastic syndrome, podocyte protein mutations.
- Treatment with cyclophosphamide within 6 months prior to study inclusion.
- Treatment with rituximab within 18 months prior to study inclusion.
- Presence of any of the contraindications to the administration of rituximab (according to the SmPC): a. Hypersensitivity to the active substance or excipients; b. Hypersensitivity to mouse proteins; c. Active infection with a severe course; d. Severe immunodeficiency*; e. Pregnancy, breastfeeding, or refusal to use effective pregnancy prevention methods during the study (applies to women); f. Severe heart failure (NYHA class IV) or severe uncontrolled heart disease. g. Post-vaccination status with a live vaccine within 4 weeks prior to study inclusion. * Immunoglobulin G deficiency secondary to nephrotic syndrome, as well as immunoglobulin G deficiency with serum IgG levels >250 g/L without a history of severe infectious complications, should not be considered as an absolute exclusion criterion. Each case should be considered individually.
- A positive result on any of the following virology tests: a. Presence of anti-HIV antibodies; b. Presence of anti-HCV antibodies** and HCV RNA viremia; c. Presence of HBs antigen. If anti-HCV antibodies are found, the patient may be eligible for the study provided that HCV RNA viremia is absent.
- Glomerular filtration rate - eGFR less than 45 ml/min/1.73m2 according to the CKD-EPI 2021 formula.
- Hypersensitivity to drugs used for premedication and prophylaxis of opportunistic infections, including corticosteroids, paracetamol, clemastine, cotrimoxazole (sulfamethoxazole+trimethoprim, SMX/TMP).
- Active neoplastic disease or history of neoplastic disease in the last 5 years.
- Any other abnormality or disease not described above that excludes the patient from the study based on the Investigator's assessment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.