Health TrialsbyHealthPanel

A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy

ConditionGlomerulonephritis, Membranous
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-79
SponsorAmgen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications).

Estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m² , ≥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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inebilizumab

    Drug

    Inebilizumab will be administered via IV infusion.

  • Tacrolimus

    Drug

    Tacrolimus will be administered orally

Treatment groups

159 Participants
are divided into 2 treatment groups
Group A: InebilizumabExperimental treatment 1 intervention
Group B: TacrolimusActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Complete Remission at Week 104

Time frame
At Week 104

Secondary outcomes

1

Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104

Time frame
At Week 104
2

Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78

Time frame
At Week 78
3

Percentage of Participants Achieving Complete Remission at Week 78

Time frame
At Week 78
4

Time to First Complete Remission by Week 104

Time frame
Up to Week 104

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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