43 Participants NeededMy employer runs this trial

Surovatamig for Membranous Nephropathy

(CLEAR-AbKD Trial)

Recruiting at 19 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Must be taking: Ace inhibitors, Arbs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called surovatamig for individuals with primary membranous nephropathy, a kidney condition that can cause swelling and protein loss in urine. Researchers aim to determine if surovatamig is safe, how it moves through the body, and whether it alleviates symptoms. Eligible participants should have primary membranous nephropathy, test positive for certain antibodies, and have tried standard kidney treatments like ACE inhibitors or angiotensin receptor blockers. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from a potentially effective new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must have been on certain blood pressure medications for at least 4 weeks before screening. You cannot have taken certain immune therapies or high-dose corticosteroids recently.

Is there any evidence suggesting that surovatamig is likely to be safe for humans?

Research has shown that surovatamig has a manageable safety profile. For example, when used alone, surovatamig proved to be very safe, with no major safety concerns reported. Other studies have demonstrated that patients, even those with recurring or hard-to-treat cancers, tolerate it well.

While these results are encouraging, they are based on earlier studies and might not include all possible side effects or risks. It's important to remember that this treatment is still under investigation, and ongoing research will provide more information. Always consult healthcare providers to fully understand the potential risks and benefits before joining a trial.12345

Why do researchers think this study treatment might be promising for membranous nephropathy?

Surovatamig is unique because it offers a new approach to treating membranous nephropathy by targeting specific proteins involved in the disease's progression. Unlike most current treatments, which often include immunosuppressants like prednisone or cyclophosphamide, Surovatamig has a distinct mechanism of action that might minimize side effects associated with suppressing the immune system. Researchers are excited about Surovatamig because it could provide a more targeted therapy, potentially leading to better outcomes and improved quality of life for patients.

What evidence suggests that surovatamig might be an effective treatment for membranous nephropathy?

Research has shown that surovatamig, a medicine that aids the immune system, has produced promising early results in treating certain conditions. In studies on other diseases, surovatamig improved outcomes for up to 59% of patients at certain doses. For membranous nephropathy, current evidence suggests that immune-focused treatments can lead to recovery. Although limited data exists on surovatamig specifically for membranous nephropathy, its interaction with the immune system offers a potential path to effectiveness. More trials are necessary to confirm its impact on this condition.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18–75 with primary membranous nephropathy who test positive for anti-PLA2R antibodies. Participants should have tried standard blood pressure medicines unless not tolerated, be up to date on vaccines, and meet other health criteria. People with certain infections, cancers, or recent use of strong immune drugs cannot join.

Inclusion Criteria

I have taken ACE inhibitors or ARBs for at least 4 weeks, unless I cannot tolerate them.
Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry
I am between 18 and 75 years old.
See 4 more

Exclusion Criteria

I have not taken high-dose steroids in the past 2 months.
I have a long-term serious lung or breathing disease.
Significant opportunistic infection in the medical history deemed relevant by the Investigator
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of surovatamig to assess safety, tolerability, pharmacokinetics, and efficacy

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Surovatamig

Trial Overview

The study is testing surovatamig given by injection under the skin to see if it is safe and effective in treating antibody-mediated kidney disease (membranous nephropathy).

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Surovatamig ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

A Study to Assess the Effect of Surovatamig in Adult ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous ...

A study to assess the effect of surovatamig in adult ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult ...

Outcomes of primary membranous nephropathy refractory to ...

The primary outcome was complete remission. Secondary outcomes included partial remission and progression to kidney failure. Findings from the included articles ...

AstraZeneca advances haematology and cell therapy ...

SYRUS Phase I/II trial: Updated safety and efficacy data for surovatamig in adolescent and adult patients with R/R B-cell acute lymphoblastic ...

Surovatamig (AZD0486), a CD19xCD3 T-cell engager ...

A dose-dependent improvement in both overall response rate (ORR) and CR rate was observed: 47%/38% at a target dose of 7.2 mg, 59%/44% at a ...

Surovatamig (AZD0486) as Monotherapy in Participants ...

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult ...

Long-Term Safety, Clinical and Immunological Outcomes in ...

Membranous nephropathy (MN) is considered a rare disease. Although up to 40% with primary MN (PMN) may develop spontaneous remission [1], PMN remains a leading ...

ICML 2025 | The safety and efficacy of surovatamig (AZD0486 ...

Soamig has demonstrated high efficacy and manageable safety profile in the rapid refractory patients as a novel CD90 targeting T- cell engager.