Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic… (NCT03298698) | Clinical Trial Compass
UnknownPhase 3
Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome
Netherlands40 participantsStarted 2018-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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