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Clinical Trials/NL-OMON44222
NL-OMON44222
Recruiting
Phase 3

Efficacy of rituximab in comparison to continued corticosteroid treatment in idiopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone. - Rituximab in SRNS

Radboud Universitair Medisch Centrum0 sites40 target enrollmentTBD
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Conditionsfocal segmental glomerulosclerosisidiopathic nephrotic syndromeminimal change disease10029149

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
focal segmental glomerulosclerosis
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
40
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age \>\= 18 years
  • •Persistent proteinuria \>\= 2 g/ 24 hours or a protein\-to\-creatinine ratio \>\= 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone 1 mg/kg/day (max 80 mg/day)
  • •Idiopathic nephrotic syndrome caused by biopsy proven minimal change disease or focal segmental glomerulosclerosis

Exclusion Criteria

  • •Severe nephrotic syndrome with hypotension
  • •Previous treatment with immunosuppressive medication other than prednisone
  • •Treatment with prednisone \> 10 weeks in last six months
  • •Secondary form of FSGS or minimal change disease
  • •Patients who test positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
  • •(anti\-HBc).
  • •Patients infected with HIV or suffering from other active infections
  • •Patients inoculated with a live vaccine within 4 weeks prior to inclusion
  • •Pregnancy, breast feeding, women with inadequate contraception
  • •Malignancy

Outcomes

Primary Outcomes

Not specified

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