Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ohio State University
With
Mallinckrodt
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients ≥ 18 years of age who have pure Class V LN or Class V+II LN diagnosed by a kidney biopsy within 4 months of screening. If a patient has segmental glomerular scarring indicative of previous Class III or IV lesions, but no evidence of current Class III or IV activity, and only the Class V component is active, they can be enrolled, despite having a mandatory ISN/RPA classification of Class V + III or IV
Proteinuria ≥ 3 g/d despite adequate blood pressure control defined as systolic blood pressure ≤ 130 mm Hg 75% of the time, per the clinical judgment of the site investigator.
Serum creatinine \< 2 mg/dl or eGFR \> 30 ml/minute
You may not be if
Patients \< 18 years of age
* Pregnancy or planning to become pregnant anytime throughout their participation in the trial, up until 30 days after last dose of study drug.
* Kidney biopsy with active Class III or IV LN
* More than 50% interstitial fibrosis and/or glomerulosclerosis on kidney biopsy
* Patients with hepatitis B, C, HIV, TB or other active and chronic infections at the time of screening
* Patients with liver disease and transaminases greater than 2.5 times the upper limit of normal of the laboratory, patients with diabetes mellitus type I or II, patients with refractory hypokalemia, patients with Cushing's Disease or Syndrome
* Patients who have been treated with cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting therapies, or experimental therapies including biologics within 6 months of screening
* Patients with active neuropsychiatric lupus, lupus pneumonitis, lupus vasculitis at screening
* Patients with high or very high extra-renal lupus activity defined as an xSLEDAI score greater than 10 at the time of screening
* Patients who have received high-dose intravenous methylprednisolone (1 g cumulative) within 3 months of screening
* Patients currently receiving, or who have received MMF or AZA in the 3 months preceding enrollment for extra-renal SLE.
* Patients who have received methotrexate or who are receiving methotrexate and it can be discontinued will be eligible; if methotrexate cannot be stopped safely, the patient will not be eligible.
* Patients currently receiving more than 20 mg/d prednisone that cannot be safely reduced to 20mg/d or less beginning at least one month before enrollment on day 0
* Patients who are not on a stable dose of Anti-Malarials and/or Anti-hypertensives at least one month preceding baseline visit and during the study. (Refer to allowed medication section)
