Glomerulonephritis, MembranousPhase 3MOMENTNCT07851220
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
A Phase 3 study testing Inebilizumab and Tacrolimus in people with Glomerulonephritis, Membranous, run by Amgen at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Glomerulonephritis, Membranous
- What is being tested?
- Inebilizumab and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2026to 26 Sep 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Bioresearch Partner-Jackson West
Doral, Florida, 33122
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
- Recruiting
Bioresearch Partner- Martin Luther King Jr.
Miami, Florida, 33127
- Recruiting
Bioresearch Partner- Pembroke Pines
Pembroke Pines, Florida, 33029
About this study
Official title: A Phase 3 Randomized, Open-Label Multicenter Study to Evaluate Efficacy and Safety of Inebilizumab in Adult Participants With Primary Membranous Nephropathy (PMN)
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.
- Conditions
- Glomerulonephritis, Membranous
- Being tested
- Inebilizumab, Tacrolimus
- Keywords
- Inebilizumab, AMG 335, Uplizna
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
Also called AMG 335 / Uplizna
Inebilizumab will be administered via IV infusion.
TacrolimusDrug
Tacrolimus will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab | Experimental | Participants will receive inebilizumab via intravenous (IV) infusion Receives: Drug: Inebilizumab |
| Tacrolimus | Active comparator | Participants will receive tacrolimus orally. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Complete Remission at Week 104
Measured: At Week 104
Secondary outcomes (17)
Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104
Measured: At Week 104
Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78
Measured: At Week 78
Percentage of Participants Achieving Complete Remission at Week 78
Measured: At Week 78
Time to First Complete Remission by Week 104
Measured: Up to Week 104
Time to First Complete Remission or Partial Remission by Week 104
Measured: Up to Week 104
Duration of Complete Remission in the Inebilizumab Arm
Measured: Up to Week 104
Percentage Change from Baseline in Anti-Phospholipase A2 Receptor (PLA2R) Antibody Levels in Anti-PLA2R Positive Participants at Week 26
Measured: From Baseline to Week 26
Number of Participants who Experienced Treatment-emergent Adverse Events, Treatment-emergent Serious Adverse Events, and Treatment-emergent Adverse Events of Interest
Measured: Up to Week 194
Number of Participants who Develop Anti-inebilizumab Antibodies
Measured: Up to Week 104
Serum Concentrations of Inebilizumab
Measured: Up to Week 160
Percentage Change from Baseline in Anti-PLA2R Antibody Levels at Week 78 and Week 104
Measured: From Baseline to Week 78 and Week 104
Time to First Relapse
Measured: From Day 1 to Week 104
Time to Initiate First Rescue Treatment
Measured: From day 1 to Week 104
Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Domain Scores at Week 78 and at Week 104
Measured: From Baseline to Week 78 and Week 104
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Score at Week 78 and at Week 104
Measured: From Baseline to Week 78 and Week 104
Change from baseline in the Estimated Glomerular Filtration Rate (eGFR)
Measured: From Baseline to Week 78 and Week 104
Percentage of Participants Achieving Stabilized eGFR at week 104, with a Decrease of ≤15 % From Baseline
Measured: From Baseline to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion27 Sep 2031 (estimated)
- Study completion26 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851220
- Sponsor's protocol ID
- 20250111
- Other IDs
- 2025-523827-23-00, 2025
- Acronym
- MOMENT
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-Label Multicenter Study to Evaluate Efficacy and Safety of Inebilizumab in Adult Participants With Primary Membranous Nephropathy (PMN)
- ClinicalTrials.gov ID
- NCT07851220
- Acronym / sponsor ID
- MOMENT / 20250111
- Conditions
- Glomerulonephritis, Membranous
- Keywords
- Inebilizumab, AMG 335, Uplizna
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 27 Sep 2031 (estimated)
- Study completion
- 26 Sep 2033 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab | Experimental | Drug: InebilizumabParticipants will receive inebilizumab via intravenous (IV) infusion |
| Tacrolimus | Active comparator | Drug: TacrolimusParticipants will receive tacrolimus orally. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InebilizumabAlso: AMG 335 / UpliznaInebilizumab will be administered via IV infusion. | Drug | Inebilizumab |
| TacrolimusTacrolimus will be administered orally | Drug | Tacrolimus |
Primary outcome
Percentage of Participants Achieving Complete Remission at Week 104
Time frame: At Week 104
17 secondary outcomes
Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104
Time frame: At Week 104
Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78
Time frame: At Week 78
Percentage of Participants Achieving Complete Remission at Week 78
Time frame: At Week 78
Time to First Complete Remission by Week 104
Time frame: Up to Week 104
Time to First Complete Remission or Partial Remission by Week 104
Time frame: Up to Week 104
Duration of Complete Remission in the Inebilizumab Arm
Time frame: Up to Week 104
Percentage Change from Baseline in Anti-Phospholipase A2 Receptor (PLA2R) Antibody Levels in Anti-PLA2R Positive Participants at Week 26
Time frame: From Baseline to Week 26
Number of Participants who Experienced Treatment-emergent Adverse Events, Treatment-emergent Serious Adverse Events, and Treatment-emergent Adverse Events of Interest
Time frame: Up to Week 194
Number of Participants who Develop Anti-inebilizumab Antibodies
Time frame: Up to Week 104
Serum Concentrations of Inebilizumab
Time frame: Up to Week 160
Percentage Change from Baseline in Anti-PLA2R Antibody Levels at Week 78 and Week 104
Time frame: From Baseline to Week 78 and Week 104
Time to First Relapse
Time frame: From Day 1 to Week 104
Time to Initiate First Rescue Treatment
Time frame: From day 1 to Week 104
Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Domain Scores at Week 78 and at Week 104
Time frame: From Baseline to Week 78 and Week 104
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Score at Week 78 and at Week 104
Time frame: From Baseline to Week 78 and Week 104
Change from baseline in the Estimated Glomerular Filtration Rate (eGFR)
Time frame: From Baseline to Week 78 and Week 104
Percentage of Participants Achieving Stabilized eGFR at week 104, with a Decrease of ≤15 % From Baseline
Time frame: From Baseline to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Related trials for Glomerulonephritis, Membranous
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inebilizumab and Tacrolimus in people with Glomerulonephritis, Membranous, run by Amgen at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Complete Remission at Week 104 (time frame: At Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.