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Clinical Trials/EUCTR2009-018266-35-BE
EUCTR2009-018266-35-BE
Active, not recruiting
Phase 1

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

CHU de LIMOGES0 sites26 target enrollmentJune 26, 2013
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ConditionsChildren with calcineurin inhibitors dependant idiopathic nephrotic syndromeMedDRA version: 14.1Level: LLTClassification code 10066701Term: Nephrotic syndrome worsenedSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsMabthera 100mgMabthera 500mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Children with calcineurin inhibitors dependant idiopathic nephrotic syndrome
Sponsor
CHU de LIMOGES
Enrollment
26
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2013
End Date
June 23, 2014
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHU de LIMOGES

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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