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

Phase 3

Recruiting

• Conditions: focal segmental glomerulosclerosis; idiopathic nephrotic syndrome; minimal change disease; 10029149

• Registration Number: NL-OMON44222
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: The proportion of patients reaching complete remission (CR)<br /><br>at 8 weeks </p><br>