A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
Amgen · NCT07851220
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–79 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 159
- US sites recruiting
- 4
- Study start
- October 1, 2026
- Record last updated
- October 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.
Being studied: Inebilizumab; Tacrolimus
Conditions: Glomerulonephritis, Membranous
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Adults aged ≥18 years and \<80 years.
- Able and willing to provide written informed consent.
- Primary membranous nephropathy (PMN) confirmed by renal biopsy (performed during screening or within 5 years before screening), or biopsy exemption for participants with anti-PLA2R antibody ≥20 RU/mL at screening.
- Participants with diabetes Hemoglobin A1c (HbA1c) \<7.5% require a renal biopsy report within 2 years before screening (or biopsy during screening) demonstrating PMN without diabetic nephropathy.
- Urine protein-to-creatinine ratio (UPCR) ≥3.5 from a 24-hour urine collection at screening.
- Receiving a maximally tolerated Angiotensin-Converting Enzyme (ACE) inhibitor or (Angiotensin II receptor blocker) ARB for ≥3 months before randomization with adequately controlled blood pressure (\<140/90 mmHg).
Exclusion Criteria
- Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications).
- Estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2 , ≥30% decline in eGFR during the previous 24 weeks, need for dialysis, kidney replacement therapy, kidney transplant, or planned transplant during the study.
- Recent thromboembolic event (within 3 months).
- Active HIV, hepatitis B infection, Hepatitis B surface antigen (HBsAg) positive, active hepatitis C infection, uncontrolled diabetes (HbA1c ≥7.5%), active or inadequately treated tuberculosis, recurrent herpes zoster or opportunistic infections, clinically significant active infection, recurrent serious infections, or immunodeficiency disorders.
- Clinically significant laboratory abnormalities, including severe anemia, neutropenia, thrombocytopenia, low Cluster of Differentiation (CD19+) B-cell count, hepatic dysfunction, or immunoglobulin G (IgG) \<400 mg/dL.
- History of solid organ or cell transplantation or progressive multifocal leukoencephalopathy.
- Recent treatment with prohibited therapies, including: B-cell-depleting biologics or other biologic immunomodulators, calcineurin inhibitors, alkylating agents within 3 months;( except history of resistance to calcineurin inhibitors); other immunosuppressive agents within 4 weeks; glucocorticoids within 1 month, or live or live-attenuated vaccines (within 4 weeks before randomization).
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Recruiting US locations
Academic Medical Research Institute
Los Angeles, CA 90022
Bioresearch Partner-Jackson West
Doral, FL 33122
Bioresearch Partner- Martin Luther King Jr.
Miami, FL 33127
Bioresearch Partner- Pembroke Pines
Pembroke Pines, FL 33029
Study contacts (from the official record)
- Amgen Call Center · 866-572-6436 · medinfo@amgen.com