NCT00908986
Withdrawn
Not Applicable
Open Label Pilot Trial of Rituximab in Lupus Membranous Nephritis
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Primary Endpoint
- Efficacy at 6 months post treatment and durability of response at 12 months post treatment will be determined by: reduction in 24 hour urinary protein excretion, reciprocal creatinine, urinary sediment
Overview
Brief Summary
The objective of this study is to assess the as efficacy of rituximab as induction therapy in membranous lupus nephritis. Safety and tolerability will additionally be assessed. Subjects will receive open-label 2 courses of rituximab at baseline and at 6 months. They will be followed monthly for 18 months to assess response and durability of response.
The hypothesis: B cell depletion will be an effective safe and well tolerated treatment for membranous lupus nephritis (Class V).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of a minimum of 18 years old
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
- •Negative serum pregnancy test (for women of child bearing potential)
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
- •Diagnosis of SLE per current ACR classification criteria (at least 4 of 11 criteria)
- •Base line proteinuria \>2g/24h
- •Kidney biopsy within 12 months of enrollment with membranous L.N. (ISN/RPS V)
- •Full dose ACE inhibition (or ARB) for a minimum of 8 weeks at day
- •Patients may be on less than full dose due to lack of tolerability
- •Stable \< 0.5mg/kg corticosteroid dose in the 4 weeks prior to screening (including no corticosteroid)
Exclusion Criteria
- •Treatment with cyclophosphamide within 3 months of screening
- •Use of high dose steroids (\>0.5 mg/kg/ day) in the 4 weeks prior to screening
- •ANC \< 1.5 x 103
- •Hemoglobin: \< 8.0 gm/dL
- •Platelets: \< 100,000/mm
- •AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
- •Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody)
- •History of positive HIV (HIV conducted during screening if applicable)
- •Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- •Receipt of a live vaccine within 4 weeks prior to randomization
Arms & Interventions
Rituximab
Experimental
Subjects receive rituximab in an open label manner
Intervention: Rituximab (Drug)
Outcomes
Primary Outcomes
Efficacy at 6 months post treatment and durability of response at 12 months post treatment will be determined by: reduction in 24 hour urinary protein excretion, reciprocal creatinine, urinary sediment
Time Frame: 12 months
Secondary Outcomes
- Change from baseline at 6 and 12 months in non-renal SLE disease activity (BILAG), lupus serologies (anti-dsDNA antibodies) and complement consumption (C3, C4), serum albumin, cholesterol, triglycerides(12 months)
Investigators
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