Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2022-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high dose prednisone .

patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with termination of prednisone or standard therapy which consist of 8 additional weeks of high dose prednisone treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Prednisolone; Prednisone; Rituximab

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 vaccine within 4 weeks prior to inclusion

• Pregnancy, breast feeding, women with inadequate contraception

• Malignancy

• Kidney transplantation

• Previous treatment with monoclonal antibodies within 2 years prior to inclusion

• Neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L

• Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease

• Active peptic ulcer

• Known hypersensitivity to glucocorticoids

• Insulin resistant diabetes mellitus

• Treatment with carbamazepine, phenobarbital, phenytoin en rifampicin

• Severe osteoporosis with vertebral fracture