A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR?CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY
- Conditions
- 05 NULL
- Registration Number
- PER-012-21
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
? Signed Informed Consent Form
? Age 18 -75 years at time of signing Informed Consent Form
? Ability to comply with the study protocol, in the investigator's judgment
? Diagnosis of pMN according to renal biopsy prior to or during screening
? 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.
? Systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg at screening
? eGFR = 40 mL/min/1.73m2 or qualified endogenous creatinine clearance = 40 mL/min based on 24-hour urine collection during screening. eGFR is calculated using the CKD-EPI equation (Levey, et al. 2009).
? Patients who previously responded to CNIs (CsA or tacrolimus), rituximab, or alkylating agents with either a CR or PR and subsequently relapsed are eligible but require discontinuation of CNIs or alkylating agents for = 6 months and rituximab for = 9 months prior to screening.
? For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 18 months after the final dose of obinutuzumab and for 28 days after the final dose of tacrolimus.
? For men receiving tacrolimus: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, as defined in the protocol.
? For patients enrolled in the extended China enrollment phase at NMPA-recognized sites: current resident of mainland China and of Chinese ancestry
? Patients with a secondary cause of MN (e.g., hepatitis B, SLE, medications, malignancies)
? Uncontrolled blood pressure, in the opinion of the investigator, during 3 months prior to screening
? Evidence of ? 50% reduction in proteinuria during the previous 6 months prior to screening
? Receipt of renal replacement therapy (e.g., renal transplantation, chronic dialysis)
? Type 1 or 2 diabetes mellitus (to exclude proteinuria secondary to diabetic nephropathy)
? Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or 28 days after the final dose of tacrolimus
? History of resistance (no response) to CNIs or B-cell depleting antibodies
? Receipt of previous therapies as indicated in protocol.
? Thrombocytopenia, anemia, and/or coagulopathy with high risk for clinically significant bleeding or organ dysfunction or requiring plasmapheresis, IV Ig, or acute blood product transfusions
? Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
? Known HIV infection
? Tuberculosis (TB) infection
? Known active infection of any kind, excluding fungal infection of the nail beds
? Any major episode of infection requiring hospitalization or treatment either with IV anti-infective treatments during the 2 months prior to or during screening or with oral anti-infective treatments during the 2 weeks prior to or during screening
? History of serious recurrent or chronic infection
? History of progressive multifocal leukoencephalopathy (PML)
? History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, except non-melanomatous carcinomas of the skin that have been treated or excised and have resolved
? 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, including other indicated per protocol.
? Laboratory parameters indicated per protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method