Actively Recruiting
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
Led by AstraZeneca · Updated on 2026-05-06
43
Participants Needed
21
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and the effectiveness of surovatamig given by subcutaneous injection in adults with primary membranous nephropathy (pMN). This condition involves antibody-mediated kidney disease with heavy and persistent proteinuria, placing participants at high risk of progressing to end-stage kidney disease. The study is a Phase II open-label trial led by AstraZeneca and includes participants positive for anti-PLA2R antibodies. The trial includes two parts: Part A with multiple ascending doses including sentinel dosing, and Part B with multiple ascending doses. Each part has three periods: screening, treatment, and follow-up, lasting up to 26 months in total. Participants will receive surovatamig by subcutaneous injection at study sites across about 10 countries. Participants will be assessed through laboratory tests including 24-hour urine collections to measure protein levels, blood tests for antibody titers and B-cell counts, and patient-reported symptom experiences. Safety will be monitored by recording adverse events over an average of two years. The main outcomes include changes in proteinuria at 6 months and adverse events throughout the study. Follow-up also includes monitoring kidney function, relapse timing, and pharmacokinetic parameters of surovatamig.
CONDITIONS
Brief Title
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 to 75 years old at the time of signing informed consent.
- Diagnosed with anti-PLA2R antibody-positive primary membranous nephropathy.
- Received standard therapy with ACE inhibitors or angiotensin receptor blockers for at least 4 weeks unless intolerant or contraindicated.
- Positive for anti-PLA2R antibodies.
- Up to date with required vaccinations as per institutional guidelines before study entry.
- Male or female assigned at birth, inclusive of all gender identities.
- Capable of giving signed informed consent.
You will not qualify if you...
- Received B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies within 9 months before screening.
- Received immunomodulatory therapy within 3 months before screening.
- Secondary causes of membranous nephropathy.
- Diabetes mellitus with hemoglobin A1C greater than 8.5% at screening.
- History of malignancies.
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome.
- Significant central nervous system co-morbidity.
- History of chronic significant respiratory disease.
- Significant opportunistic infection deemed relevant by the investigator.
- Abnormal vital signs after 10 minutes sitting at rest.
- Use of corticosteroids exceeding 20 mg prednisolone or equivalent within 2 months before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 months
Participants receive Surovatamig subcutaneously to assess its safety, tolerability, pharmacokinetics, and efficacy.
Visits scheduled throughout treatment period up to 26 months
Duration - Up to 26 months
Participants are monitored for safety and treatment effects after completing treatment with Surovatamig.
Periodic visits during follow-up period up to 26 months
Trial Site Locations
Total: 21 locations
1
Research Site
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Research Site
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
3
Research Site
Bethesda, Maryland, United States, 20889
Not Yet Recruiting
4
Research Site
New York, New York, United States, 10016
Not Yet Recruiting
5
Research Site
Houston, Texas, United States, 77027
Actively Recruiting
6
Research Site
Houston, Texas, United States, 77030
Not Yet Recruiting
7
Research Site
Ieper, Belgium, 8900
Not Yet Recruiting
8
Research Site
Bordeaux, France, 33076
Not Yet Recruiting
9
Research Site
Créteil, France, 94010
Withdrawn
10
Research Site
Lyon, France, 69009
Not Yet Recruiting
11
Research Site
Nantes, France, 44093
Not Yet Recruiting
12
Research Site
Nîmes, France, 30029
Not Yet Recruiting
13
Research Site
Düsseldorf, Germany, 40225
Not Yet Recruiting
14
Research Site
Brescia, Italy, 25123
Not Yet Recruiting
15
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
16
Research Site
Torino, Italy, 10154
Not Yet Recruiting
17
Research Site
Verona, Italy, 37126
Withdrawn
18
Research Site
Lodz, Poland, 92-213
Not Yet Recruiting
19
Research Site
Barcelona, Spain, 08025
Not Yet Recruiting
20
Research Site
Madrid, Spain, 28041
Not Yet Recruiting
21
Research Site
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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