EUCTR2017-003366-27-NL
Active, not recruiting
Phase 1
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 University Nijmegen Medical Center0 sites40 target enrollmentOctober 10, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud University Nijmegen Medical Center
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 35
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 5
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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