Primary Membranous NephropathyPhase 2CLEAR-AbKDNCT07571746
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
A Phase 2 study testing Surovatamig in people with Primary Membranous Nephropathy, run by AstraZeneca at 27 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Surovatamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 28 Mar 2026to 15 Apr 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Diagnosis of anti-PLA2R antibody-positive pMN.
- 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.
- Positive for anti-PLA2R.
- Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
- 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.
- Capable of giving signed informed consent
Who cannot join
- Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies < 9 months before screening.
- Immunomodulatory therapy <3 months before screening.
- Secondary causes of membranous nephropathy
- Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
- Malignancies
- 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.
Trial locations and contacts
27 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
27 sites in 9 countries
United States7 sites, 6 recruiting
- Not yet recruiting
Research Site
Bethesda, Maryland, 20889
- Recruiting
Research Site
Houston, Texas, 77027
- Not yet recruiting
Research Site
Houston, Texas, 77030
- Not yet recruiting
Research Site
Iowa City, Iowa, 52242
- Withdrawn
Research Site
Los Angeles, California, 90022
- Not yet recruiting
Research Site
Los Angeles, California, 90095
- Not yet recruiting
Research Site
New York, New York, 10016
France5 sites, 4 recruiting
- Not yet recruiting
Research Site
Bordeaux, 33076
- Withdrawn
Research Site
Créteil, 94010
- Not yet recruiting
Research Site
Lyon, 69009
- Not yet recruiting
Research Site
Nantes, 44093
- Not yet recruiting
Research Site
Nîmes, 30029
Italy4 sites, 3 recruiting
- Not yet recruiting
Research Site
Brescia, 25123
- Not yet recruiting
Research Site
Rozzano, 20089
- Not yet recruiting
Research Site
Torino, 10154
- Withdrawn
Research Site
Verona, 37126
Germany3 sites, 3 recruiting
- Not yet recruiting
Research Site
Düsseldorf, 40225
- Not yet recruiting
Research Site
Hanover, 30625
- Not yet recruiting
Research Site
München, 80336
China2 sites, 2 recruiting
- Not yet recruiting
Research Site
Beijing, 100034
- Not yet recruiting
Research Site
Beijing, 102218
Spain2 sites, 2 recruiting
- Not yet recruiting
Research Site
Barcelona, 08025
- Not yet recruiting
Research Site
Madrid, 28041
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Research Site
London, NW3 2PF
- Not yet recruiting
Research Site
Manchester, M13 9WL
About this study
Official title: A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
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.
Read the detailed description
This is a Phase II open-label study to assess the safety, tolerability, Pharmacokinetics, and efficacy of surovatamig in adult participants with pMN, who are positive for anti-PLA2R antibodies and have heavy and persistent proteinuria with a high risk of progressing to end stage kidney disease.
The study will be conducted across approximately 30 to 40 study sites in approximately 10 countries. The study consists of 2 parts (Part A Multiple ascending with sentinel dosing and Part B Multiple ascending doses), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Surovatamig
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurovatamigDrug
Participants will receive Surovatamig subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Surovatamig Arm | Experimental | Participants will receive Surovatamig Receives: Drug: Surovatamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
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.
Measured: Through study completion, an average of 2 years
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
Measured: At 6 months
Secondary outcomes (12)
Percentage of participants achieving complete or partial remission of pMN
To evaluate the proportion of participants who achieve partial and/or complete remission
Measured: At 24 months
Percentage of participants achieving complete remission of pMN
To evaluate the proportion of participants who achieved complete remission
Measured: At 24 months
Percentage of participants achieving partial remission of pMN
To evaluate the proportion of participants who achieve partial remission
Measured: At 24 months
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
Measured: At 24 months
Change from baseline in anti-PLA2R antibody titer
To evaluate anti-PLA2R antibodies in blood
Measured: At 24 months
Change from baseline in B-cell count in peripheral blood
To assess the effect of surovatamig by assessment of B-cell depletion in blood
Measured: At 24 months
Time to relapse after complete or partial remission
Time to relapse after complete or partial remission
Measured: At 24 months
Time to a ≥ 3 months sustained reduction of eGFR
Time to a sustained reduction of eGFR
Measured: From Baseline to 24 months
Change from baseline in patient-reported experience of symptoms associated with pMN
To evaluate the change in patient-reported experience
Measured: Through study completion, an average of 2 years
Serum PK parameters of surovatamig, AUC Area under the plasma concentration versus time curve
To characterise the PK of surovatamig
Measured: Through study completion, an average of 2 years
Treatment-emergent ADAs
To evaluate the immunogenicity of surovatamig
Measured: Through study completion, an average of 2 years
Serum PK parameters of surovatamig, as Cmax (Peak Plasma Concentration)
To characterise the PK of surovatamig
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start28 Mar 2026
- Primary completion13 Oct 2028 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study consists of 2 parts (Part A and Part B), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571746
- Sponsor's protocol ID
- D740FC00001
- Other IDs
- 2025-524139-38-00, NCT07571746, 2025
- Acronym
- CLEAR-AbKD
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.