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Kidney drug trial pulled before it even started

NCT ID NCT06120673

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This was a planned study to compare a newer drug, obinutuzumab, against a standard treatment (steroids plus cyclophosphamide) for people with primary membranous nephropathy, a kidney disease that causes protein leakage. The goal was to see which treatment worked better and had fewer side effects. However, the trial was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Obinutuzumab
What this could lead to
If successful, obinutuzumab could offer a new treatment option for primary membranous nephropathy with fewer side effects than current therapies.
What could go wrong
The trial was withdrawn before enrolling any participants, so no data is available. It is unclear if obinutuzumab is effective or safe for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years. 2. Able to provide informed consent. 3. Primary Membranous Nephropathy (PMN) confirmed by: 1. Kidney biopsy (anti-PLA2R negative patients are eligible for inclusion if PMN is confirmed on biopsy. Kidney biopsy is generally encouraged to confirm diagnosis of PMN) or 2. if the clinician decides against a biopsy, the patient must be anti-PLA2R positive and must not have diabetes. 4. Proteinuria ≥4 g/24h despite supportive treatment for at least 6 months with maximally tolerated dose of ACE-i or ARB (dose to be stable for at least 4 weeks), confirmed at final screening before randomisation 5. Serum albumin \<30 g/L. 6. Estimated glomerular filtration rate (eGFR) ≥40 ml/min/1.73m2. 7. Treatment with immunosuppression is warranted, as determined by the treating physician. 8. Fully vaccinated against COVID-19 according to local practice/recommendation. Exclusion Criteria: 1. Resistant to rituximab or have had \>2 g of rituximab in the past. 2. Resistant to cyclophosphamide or have had a cumulative \>20 g of cyclophosphamide in the past. 3. More than 3 years since PMN diagnosis. 4. Proteinuria must not have decreased by \>50% over 6 months whilst taking ACE-i/ARB. 5. Patients with human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or other active infections. 6. Patients with secondary membranous nephropathy 7. Screening for malignancy must be considered especially in cases who are anti-PLA2R negative. 8. Patients whose kidney biopsy shows concomitant features of diabetic nephropathy. 9. Kidney transplant recipients. 10. Pregnancy or breastfeeding. 11. Women of childbearing age not willing to use contraception. 12. Suspected or known hypersensitivity, allergy, and/or immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups. 13. Any disorder or condition, in the opinion of the investigator, might pose an unacceptable risk to participant's safety and well-being. 14. Inability to understand or comply with the requirements of the study. 15. Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent are excluded, even if they have a legal representative. 16. Use of an investigational agent \<30 days or within five half-lives of the investigational agents (whichever is longer), whose effect or toxicity may overlap with that of obinutuzumab, prednisolone, cyclophosphamide, or their metabolites. 17. Active Tuberculosis infection. Testing for latent disease may be performed at screening if required by local regulations or in accordance with local clinical practice. Latent disease after completion of appropriate treatment is not exclusionary. 18. Low peripheral B-cell count (as per local reference range) . B-cell count must be checked, particularly in those who have received rituximab, cyclophosphamide or both anytime in the past. 19. Use of SGLT2-i and GLP-1 agonist within 90 days prior to randomisation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bundaberg Hospital

    Bundaberg, Queensland, Australia

  • Cairns Hospital

    Cairns, Queensland, Australia

  • Canberra Hospital

    Garran, Australian Capital Territory, Australia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, Australia

  • Logan Hospital

    Logan City, Queensland, Australia

  • Mackay Base Hospital

    Mackay, Queensland, Australia

  • Mater Hospital

    South Brisbane, Queensland, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

  • Rockhampton Hospital

    Rockhampton, Queensland, Australia

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • Sunshine Coast University Hospital

    Birtinya, Queensland, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.