Overview

Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome

Status:
Terminated
Trial end date:
2020-08-31
Target enrollment:
0
Participant gender:
All
Summary
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome. This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil, the reference standard therapy. The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Istituto Giannina Gaslini
Collaborator:
Bambino Gesù Hospital and Research Institute
Treatments:
Mycophenolic Acid
Rituximab
Criteria
Inclusion Criteria:

To be eligible for inclusion into this study, participants will have to fulfil the
following criteria:

- Age between 3 and 24 years

- Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at
least six months before enrolment. Steroid dependence is defined by two consecutive
relapse during corticosteroid therapy or within 14 days of ceasing therapy.

- 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normal medical care, with the understanding that consent may be withdrawn by the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:

Children will be excluded if any of the following criteria apply:

- Positivity to autoimmunity tests (ANA, nDNA, ANCA)

- Reduction of C3 levels.

- eGFR<90/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