RECRUITING

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

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Conditions

Primary Membranous NephropathyPMNALXN1920

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression

Quick Facts

Study Start:2025-09-19
Study Completion:2027-03-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07157787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 50 RU/mL) at Screening, which must be confirmed by a central laboratory
  2. * Participants are willing to receive the background Standard of Care (SoC)
  3. * Participants at high risk for disease progression, defined as:
  4. 1. 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 have not yet reached maximally tolerated dose will enter the Run-in Period.
  5. 2. 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.
  6. 3. Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
  7. * All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
  1. * Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m\^2 during Screening
  2. * Documented rapid deterioration of kidney function
  3. * History of life-threatening Nephrotic Syndrome within 1 year before Screening
  4. * Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 50 RU/mL or kidney disease other than PMN
  5. * History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
  6. * History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
  7. * History or presence of any clinically relevant co-morbidities
  8. * History of intolerance or hypersensitivity to ACEi or ARB
  9. * Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Research Site
Loma Linda, California, 92354
United States
Research Site
San Diego, California, 92123
United States
Research Site
Minneapolis, Minnesota, 55435
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-19
Study Completion Date2027-03-12

Study Record Updates

Study Start Date2025-09-19
Study Completion Date2027-03-12

Terms related to this study

Keywords Provided by Researchers

  • Primary Membranous Nephropathy
  • PMN
  • ALXN1920

Additional Relevant MeSH Terms

  • Primary Membranous Nephropathy