Clinical Trials in Spain / NCT07571746
Recruiting
Phase 2
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
NCT07571746 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Primary Membranous Nephropathy
Investigational drug(s) / intervention(s)
Surovatamig: Participants will receive Surovatamig subcutaneously
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Number of participants with adverse events. — Through study completion, an average of 2 years
To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig. - Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) — At 6 months
To assess the effect of surovatamig on proteinuria
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Angeles | California | Withdrawn |
| Research Site | Los Angeles | California | Not Yet Recruiting |
| Research Site | Iowa City | Iowa | Not Yet Recruiting |
| Research Site | Bethesda | Maryland | Not Yet Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Houston | Texas | Not Yet Recruiting |
| Research Site | Ieper | Belgium | Not Yet Recruiting |
| Research Site | Bordeaux | France | Not Yet Recruiting |
| Research Site | Créteil | France | Withdrawn |
| Research Site | Lyon | France | Not Yet Recruiting |
| Research Site | Nantes | France | Not Yet Recruiting |
| Research Site | Nîmes | France | Not Yet Recruiting |
| Research Site | Düsseldorf | Germany | Not Yet Recruiting |
| Research Site | München | Germany | Not Yet Recruiting |
| Research Site | Brescia | Italy | Not Yet Recruiting |
| Research Site | Rozzano | Italy | Not Yet Recruiting |
| Research Site | Torino | Italy | Not Yet Recruiting |
| Research Site | Verona | Italy | Withdrawn |
| Research Site | Lodz | Poland | Not Yet Recruiting |
| Research Site | Barcelona | Spain | Not Yet Recruiting |
| Research Site | Madrid | Spain | Not Yet Recruiting |
| Research Site | London | United Kingdom | Not Yet Recruiting |
| Research Site | Manchester | United Kingdom | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07571746 on ClinicalTrials.gov ↗ ← All trials in Spain