Efficacy of rituximab for the treatment of calcineurin inhibitors dependant nephrotic syndrome during childhood

Phase 1

• Conditions: Children with calcineurin inhibitors dependant idiopathic nephrotic syndrome; MedDRA version: 14.1Level: LLTClassification code 10066701Term: Nephrotic syndrome worsenedSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-018266-35-BE
• Lead Sponsor: CHU de LIMOGES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-26
• Study Completion: 2014-06-23
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

- 2 to 18 years old
- idiopathic steroid dependent and calcineurin inhibitors dependant nephrotic syndrome
- nephrotic relapse during the last 6 months
- patient in remission at inclusion
- effective contraception for female of child bearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range: 26
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

- end stage renal failure
- rituximab contre-indication
- transcutaneous oxygen saturation < 97%
- pleural pulmonary or bronchus lesion
- hepatitis B carrier or medical history of hepatitis B
- patient or parents refusing to participate into the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of rituximab in the treatment of children with calcineurin inhibitors dependent nephrotic syndrome;Secondary Objective: - toxicity during and after rituximab infusion<br>- pharmacokinetics of rituximab<br>- modification of lymphocyte phenotyping by rituximab<br>- Quality of Life throughout the trial<br>;Primary end point(s): relapse of nephrotic syndrome within 5 months after infusion;Timepoint(s) of evaluation of this end point: at 5 months post treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - toxicity during and after rituximab infusion<br>- General safety assessement (AE/SAE)<br>- pharmacokinetics samples<br>- modification of lymphocyte phenotyping by rituximab<br>- Quality of Life questionnaires (PedsQL)<br>;Timepoint(s) of evaluation of this end point: - Specific toxicity of rituximab assessed during the IMP administration and up to 4h after the infusion<br>- General Safety assessment recorded throughout the study <br>- PK samples taken just before and 2H after infusions<br>- PedsQL Questionnaire completed at inclusion and at months 5<br>- Lymphocyte phenotyping at each study visit