Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome

Launched by ISTITUTO GIANNINA GASLINI · Jan 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two specific medications in treating children and young adults with nephrotic syndrome, a condition that causes the body to lose too much protein in the urine. The trial aims to see if combining a drug that targets CD20, a type of immune cell, with another drug that targets plasma cells can help patients who have not responded well to standard treatments. These patients often struggle with a condition known as multidrug-dependent or multidrug-resistant nephrotic syndrome, which means their symptoms do not improve despite taking multiple medications.

To be eligible for this trial, participants must be between 3 and 24 years old and have been diagnosed with nephrotic syndrome that is dependent on or resistant to multiple drugs for at least six months. They should have experienced two relapses while on treatment or not responded to treatments as expected. Parents or guardians will need to provide consent, and the participants themselves will also need to agree to take part in the study. Those who are pregnant, have certain infections, or have had specific recent treatments will not be eligible. Participants can expect to receive careful monitoring throughout the study and may contribute to important research that could help others with similar health challenges in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 3 and 24 years
• • Multidrug dependent or resistant nephrotic syndrome for at least six months before enrolment. The need of at least 2 of the oral drugs listed below defines multidrug-dependence: prednisone at any doses, MMF 1200 mg m2 and CNI 0.1 mg day given in two doses. Dependence is defined by two consecutive relapses during double therapies or within 14 days of ceasing one of the three components of the therapeutic approach. Resistance is defined as lack of antiproteinuric effect of a double therapy based on steroid plusCNI or mofetilmycophenolate (MMF).Steroid resistance is defined by failure to achieve complete remission after 6 weeks with prednisone60 mg/m2.
• • Post transplant recurrence of FSGS.
• • Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.
• Exclusion Criteria:
• • Positivity to autoimmunity tests (ANA, nDNA, ANCA)
• • Reduction of C3 levels.
• • eGFR\<60/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
• • Pregnancy
• • Neoplasm
• • Infections: previous or actual HBV (with HBeAb positivity) or HCV infection
• • CD20 B lymphocytes count \<2,5%
• • Treatment with Rituximab or cyclophosphamide in the last 6 months