Efficacy of immunoglobulins in pediatric early-onset corticosteroid nephrotic syndrome

Phase 1

Conditions: Childhood-Onset steroid-dependent nephrotic syndrome
MedDRA version: 20.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2017-000826-36-FR

Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

- Childhood onset nephrotic syndrome (first flair at age> 2 years and <18 years)
- Steroid-dependent:
*Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.
*Patient with at least 2 relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide) or following treatment withdrawal.
- or with frequent relapses:
*2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.
- with a relapse within 3 months prior to inclusion
- In remission: Protein-over-creatinine ratio <- 0.2g/g (<- 0.02g/mmol)

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with steroid-resistant nephrotic syndrome;
- Patients with genetic nephrotic syndrome;
- Patients previously treated with rituximab;
- Patients with no affiliation to a social security scheme (beneficiary or legal);
- Prior hepatitis B infection;
- Pregnancy or breastfeeding.
- Patients with hyperprolinaemia,
- Known hypersensitivity to one of the study medication,
- Scheduled and not postponable injection of live attenuated vaccine