Status:
UNKNOWN
Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome
Lead Sponsor:
Radboud University Medical Center
Conditions:
Idiopathic Nephrotic Syndrome
Minimal Change Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dise...
Detailed 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 assoc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 22 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03298698
Start Date
August 22 2018
End Date
January 22 2022
Last Update
August 27 2018
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands, 6500HB