The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
1800 mg administered by subcutaneous injection by manual push over approximately 3-5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Efficacy of daratumumab in inducing complete(CR) or partial(PR) renal remission in patients with active class III or IV Lupus Nephritis
Complete Renal Response:- \< 500 mg proteinuria/24 hours, Inactive urinary sediment (\<10 RBC/HPF and absence of RBC casts), No greater than a 15% reduction in eGFR from enrollment
Time frame: 12 months after first infusion of Daratumumab
Efficacy of daratumumab in inducing complete(CR) or partial(PR)
Partial Renal Response: \> 50% reduction in 24-hour proteinuria and proteinuria \< 1g/24hr if baseline 24hr proteinuria, - ≤3 g/24hr and proteinuria ≤ 3 g/24hr if starting proteinuria \> 3 g/24hrs. , Improved urinary sediment (\>=50% reduction in RBC/HPF and absence of RBC casts), No greater than a 20% reduction in baseline eGFR
Time frame: 12 months after first infusion of Daratumumab
Safety of daratumumab in patients with active class III/IV LN.
Incidence of major infections defined in the development of pneumonia, grade 3 urinary tract infection/pyelonephritis, sepsis, meningitis or anemia.
Time frame: 24 months after first infusion of Daratumumab
Improvement from proteinuria
Change in proteinuria in milligrams (mg) per 24h
Time frame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab
Change in hematuria.
Improvement in hematuria from baseline as measured by the urinalysis
Time frame: Baseline,6, 12, 18 and 24 months after first infusion of Daratumumab
Improvement in eGFR
Improvement in eGFR measured using the chronic kidney disease epidemiology collaboration (CKD-EPI) Equation: eGFR (CKD-EPI) = 141 x min(Scr/k, 1)alpha x max(Scr/k,1)-1.209 x 0.993age x 1.018 (if patient is female) x 1.159 (if patient is black)
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Time frame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab
Change in ds-DNA
Improvement in ds-DNA in International units per milliliter (IU/mL)
Time frame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab