Description

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in patients with primary membranous nephropathy (pMN).

Is there compensation for this trial? Yes

Am I Eligible or this trial?

Below is the detailed inclusion and exclusion detail for the the trial. Some of these you may know and other we may need to test in order to determine if you are a good fit for the trial. If you are not sure, please fill out the form to the left and one of our researchers will call you to assist in determining this and answering any additional questions.

Inclusion Criteria:

• Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening

• Urinary protein-to-creatinine ratio (UPCR) >= 5 g from 24-hour urine collection despite best supportive care for >= 3 months prior to screening or UPCR >= 4 g despite best supportive care >= 6 months prior to screening

• eGFR >= 40 mL/min/1.73m2 or qualified endogenous creatinine clearance >= 40 mL/min based on 24-hour urine collection during screening

• Other inclusion criteria may apply

Exclusion Criteria:

• Patients with a secondary cause of MN

• Pregnancy or breastfeeding

• Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to screening

• Severe renal impairment, including the need for dialysis or renal replacement therapy

• Type 1 or 2 diabetes mellitus

• Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening

• Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation

• Known active infection of any kind or recent major episode of infection

• Major surgery requiring hospitalization within the 4 weeks prior to screening

• Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening

• Intolerance or contraindication to study therapies

• Other exclusion criteria may apply