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New treatment option for Primary Membranous Nephropathy
Official title Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
ClinicalTrials.gov ID: NCT07157787
What this study is testing
What is ALXN1920?
ALXN1920 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 20 RU/mL) at Screening, which must be...
- Participants are willing to receive the background Standard of Care (SoC)
- Participants at high risk for disease progression, defined as:
- Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants...
- Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8...
You likely can't join if
- Documented rapid deterioration of kidney function
- History of life-threatening Nephrotic Syndrome within 1 year before Screening
- Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \<...
- History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
- History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment...
- History or presence of any clinically relevant co-morbidities
See the full eligibility criteria
- Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 20 RU/mL) at Screening, which must be confirmed by a central laboratory
- Participants are willing to receive the background Standard of Care (SoC)
- Participants at high risk for disease progression, defined as:
- Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who...
- Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks.
- Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
- eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
- All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
- Documented rapid deterioration of kidney function
- History of life-threatening Nephrotic Syndrome within 1 year before Screening
- Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 20 RU/mL or kidney disease other than PMN
- History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
- History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
- History or presence of any clinically relevant co-morbidities
- History of intolerance or hypersensitivity to ACEi or ARB
- Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period.
- Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening.
- Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period Note: Additional inclusion/exclusion criteria may apply, per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- San Diego, California, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Houston, Texas, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Ciudad de Buenos Aires, Argentina
- La Plata, Argentina
- Rosario, Argentina
- Santa Fe, Argentina
- Gosford, Australia
- Parkville, Australia
- Southport, Australia
- Recife, Brazil
- Salvador, Brazil
- São Paulo, Brazil
- Baotou, China
- Beijing, China
- Guangzhou, China
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; San Diego, California, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; Houston, Texas, United States; Buenos Aires, Argentina and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.