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

  • STATUS
    Recruiting
  • End date
    Jan 22, 2022
  • participants needed
    40
  • sponsor
    Radboud University
Updated on 22 January 2021
corticosteroids
rituximab
prednisone
total protein
proteinuria
prednisone 1 mg
nephrotic syndrome
minimal change disease

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.

Description

Minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) are important causes of idiopathic nephrotic syndrome. First-line treatment with high dose prednisone up to 16 weeks is associated with serious side effects. Especially if treatment continues for more than 8 weeks.

Retrospective studies suggested that Rituximab may be more effective in patients unresponsive to 8 weeks of high dose prednisone. Treatment with rituximab was associated with a higher proportion of patients attaining remission of proteinuria and with fewer side effects.

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 an idiopathic nephrotic syndrome due to biopsy proven MCD or FSGS age 18 years or older.

All patients will be treated with high dose prednisone (1 mg/kg/day) for 8 weeks.

Patients can be included in the trial in case of persistent 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

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. In the Rituximab group, B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval (maximum of 2 additional doses) until complete B cell depletion.

Expected duration of the follow-up is 12 months, consisting of 9 visits.

Details
Condition Focal glomerulosclerosis, Glomerulonephritis, Lipoid nephrosis, Focal Segmental Glomerulosclerosis, minimal change disease
Treatment Rituximab, prednisone
Clinical Study IdentifierNCT03298698
SponsorRadboud University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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