Efficacy of Ofatumumab in children with steroid-dependent nephrotic syndrome a

Phase 1

• Conditions: steroid dependent nephrotic syndrome; MedDRA version: 20.0Level: HLTClassification code 10018365Term: Glomerulonephritis and nephrotic syndromeSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001042-33-IT
• Lead Sponsor: IRCCS Istituto Giannina Gaslini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-11
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 160

Inclusion 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any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified