Inebilizumab for primary membranous nephropathy in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating the efficacy of inebilizumab, given with tacrolimus, to induce complete remission in adults with primary membranous nephropathy. Participants must have biopsy-confirmed PMN (or anti-PLA2R result supporting PMN) and substantial proteinuria, and be on stable ACE inhibitor or ARB therapy. The study enrolls adults aged 18 to under 80 and uses renal outcomes to measure disease activity. Primary and secondary endpoints will assess remission rates and safety in comparison to standard care. The trial is sponsored by Amgen with several site-based partners in California and Florida.

Why it matters

Who can join: the full rules

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.

Where it's running

• Academic Medical Research Institute
  Los Angeles, California, United States Recruiting
• Bioresearch Partner-Jackson West
  Doral, Florida, United States Recruiting
• Bioresearch Partner- Martin Luther King Jr.
  Miami, Florida, United States Recruiting
• Bioresearch Partner- Pembroke Pines
  Pembroke Pines, Florida, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.