A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Recruiting
Phase 2Interventional Study
Primary Membranous Nephropathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
43 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adult participants with a specific kind of kidney disease called primary membranous nephropathy. Participants will receive a treatment called surovatamig through an injection to see how safe and effective it is.
Are You a Good Fit for This Trial?
Must be takingACE inhibitorsAngiotensin receptor blockers
Must not be takingCorticosteroids
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with anti-PLA2R antibody-positive primary membranous nephropathy.
I have been taking certain medications for my kidney condition for at least 4 weeks.
I have a positive test for anti-PLA2R antibodies.
I am up to date with required vaccinations.
I can give signed informed consent.
You may not be able to join if
I have received specific B cell therapies in the last 9 months.
I have had certain immunomodulatory treatments in the last 3 months.
I have a different cause for my kidney condition.
I have diabetes with a blood sugar level above 8.5%.
I have a history of cancer.
I have a history of serious immune system problems.
I have a significant history of chronic lung disease.
I have had a significant infection that my doctor thinks is important.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
2. Diagnosis of anti-PLA2R antibody-positive pMN.
3. All participants must have received SoC …
Inclusion Criteria:
1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
2. Diagnosis of anti-PLA2R antibody-positive pMN.
3. All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.
4. Positive for anti-PLA2R.
5. Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
6. Male and/or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
7. Capable of giving signed informed consent
Exclusion Criteria:
1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies \< 9 months before screening.
2. Immunomodulatory therapy \<3 months before screening.
3. Secondary causes of membranous nephropathy
4. Diabetes mellitus with haemoglobin A1C \> 8.5% tested at screening visit.
5. Malignancies
6. History of HLH/MAS. 7 Significant CNS co-morbidity
8\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.
10\. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent \< 2 months before screening.
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