Not Authorised Therapeutic exploratory (Phase II) Complicated forms of idiopathic steroid-sensitive nephrotic syndrome (SSNS)

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

EU CTIS ID: 2024-511214-20-00

What this study is testing

To define the optimal number of RTX re-infusions in children with complicated forms of FRNS/SDNS through an open-label randomized controlled trial comparing two different regimens for repeated RTX treatment based on the reconstitution of total B cells (Arm A) or memory B cells (Arm B).

  • Therapeutic exploratory (Phase II)

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

  • 1.Prior to any study procedure, informed consent must be obtained in written form from the adult patient or from both parents/legal guardians of the pediatric patient. For adolescent and school-aged patients, assent will be obtained with age-appropriate information. 2.Children and young adults (aged 3 to 24 years) with complicated forms of FRNS/SDNS (see "Definitions") who have at least 2 relapses per year while on mycophenolate mofetil (MMF) and/or a calcineurin inhibitor at appropriate doses (3-5 mg/kg in 2 daily doses). 3.Previous infusions of RTX will be allowed. 4.Patients, if of legal age, and parents or legal guardians if minors, must be able to communicate adequately with the medical team and understand and carry out the necessary procedures for completing the study. 5.For patients with reproductive potential (females), the use of a reliable contraceptive method (e.g., abstinence, barrier contraception, hormonal contraception) for the entire duration of study participation is required.

You likely can't join if

  • At screening, patients with any of the following characteristics will not be considered eligible for enrollment: 1. Corticosteroid resistance, defined as lack of response to 4 weeks of oral prednisone at standard dosage. 2. Onset of nephrotic syndrome after the age of 18. 3. Secondary nephrotic syndrome. 4. Past or present malignant tumors of any organ or system, even in the absence of active or previous metastatic signs or symptoms. 5. Pregnancy (defined as the condition of a female individual from conception until the end of gestation, confirmed by a positive laboratory test for beta human chorionic gonadotropin (hCG)) or breastfeeding. Women of childbearing age (from menarche onward) must use an effective contraceptive method (complete abstinence, barrier contraception, or hormonal contraception) throughout the duration of the study and for 12 months following the last study RTX infusion. 6. Lack of response to rituximab or mycophenolate mofetil, defined as persistence of nephrotic proteinuria >4 weeks despite such therapy. 7. Active severe infection, for example, hepatitis B (positive HBsAg, HBcAb), sepsis, or active tuberculosis (positive Quantiferon). 8. Severe immunosuppression, defined as congenital immunodeficiency and/or as circulating immunoglobulin levels 2x lower than the minimum normal range for age and/or as circulating neutrophil granulocytes <1.5x10^3/μl. 9. Renal insufficiency with eGFR < 15 ml/min/1.73 m² calculated using the modified Schwartz formula (for children) or the Cockcroft-Gault formula (for adults). 10. Severe heart failure (New York Heart Association class IV) or severe uncontrolled heart disease. 11. Known hypersensitivity to RTX treatment. 12. Known hypersensitivity to concomitant medications (prednisone, mycophenolate mofetil/mycophenolic acid, calcineurin inhibitors). 13. Use of live attenuated vaccines within 28 days prior to enrollment and throughout the duration of the study. 14. Weight < 10 kg. 15. Thrombocytopenia, defined as platelet level <100,000/mm². 16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5x the upper limit of the normal range for age and sex.

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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

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.