Kidney drug trial pulled before it even started
NCT ID NCT06120673
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 However, the trial was withdrawn before enrolling any participants, so no results are available.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- The trial was withdrawn before enrolling any participants, so no data is available.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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Bundaberg Hospital
Bundaberg, Queensland, Australia
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Cairns Hospital
Cairns, Queensland, Australia
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Canberra Hospital
Garran, Australian Capital Territory, Australia
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Fiona Stanley Hospital
Murdoch, Western Australia, Australia
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Logan Hospital
Logan City, Queensland, Australia
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Mackay Base Hospital
Mackay, Queensland, Australia
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Mater Hospital
South Brisbane, Queensland, Australia
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Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
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Rockhampton Hospital
Rockhampton, Queensland, Australia
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Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
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Royal Hobart Hospital
Hobart, Tasmania, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
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Sunshine Coast University Hospital
Birtinya, Queensland, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug zuberitamab takes aim at kidney disease in phase 3 trial
- A new tool to predict kidney failure risk in membranous nephropathy?
- Can engineered immune cells tackle a tough kidney disease?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can engineered immune cells tame autoimmune kidney disease?
- Can a pill calm the immune attack on kidneys?