Comparison of rituximab with prolonged treatment with prednisone in patients with idiopathic nephrotic syndrome

Phase 1

• Conditions: Idiopathic nephrotic syndromeFocal segmental glomerulosclerosisMinimal change disease; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2017-003366-27-NL
• Lead Sponsor: Radboud University Nijmegen Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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
• Kidney transplantation
• Previous treatment with monoclonal antibodies

Study & Design

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