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Primary Membranous NephropathyPhase 3REMITNCT06120673

REmission in Membranous Nephropathy International Trial (REMIT)

A Phase 3 study testing Obinutuzumab and Oral prednisolone and cyclophosphamide in people with Primary Membranous Nephropathy, run by The University of Queensland at 13 sites in Australia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

REMIT is an investigator-initiated, international, multi-centre, prospective, randomised, open-label, parallel-group trial. A total of 224 adult participants with Primary Membranous Nephropathy (PMN) will be recruited from renal units from Australia, New Zealand Canada, Asia, Europe, United Kingdom, and other… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Membranous Nephropathy
What is being tested?
Obinutuzumab and Oral prednisolone and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
13 sitesAustralia
Study dates
31 Oct 2025to 31 Jan 2028
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Able to provide informed consent.
  • Primary Membranous Nephropathy (PMN) confirmed by:
  • 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
  • if the clinician decides against a biopsy, the patient must be anti-PLA2R positive and must not have diabetes.
  • 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
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  • Serum albumin <30 g/L.
  • Estimated glomerular filtration rate (eGFR) ≥40 ml/min/1.73m2.
  • Treatment with immunosuppression is warranted, as determined by the treating physician.
  • Fully vaccinated against COVID-19 according to local practice/recommendation.

Who cannot join

  • Resistant to rituximab or have had >2 g of rituximab in the past.
  • Resistant to cyclophosphamide or have had a cumulative >20 g of cyclophosphamide in the past.
  • More than 3 years since PMN diagnosis.
  • Proteinuria must not have decreased by >50% over 6 months whilst taking ACE-i/ARB.
  • Patients with human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or other active infections.
  • Patients with secondary membranous nephropathy
Show all 19Show fewer
  • Screening for malignancy must be considered especially in cases who are anti-PLA2R negative.
  • Patients whose kidney biopsy shows concomitant features of diabetic nephropathy.
  • Kidney transplant recipients.
  • Pregnancy or breastfeeding.
  • Women of childbearing age not willing to use contraception.
  • 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.
  • Any disorder or condition, in the opinion of the investigator, might pose an unacceptable risk to participant's safety and well-being.
  • Inability to understand or comply with the requirements of the study.
  • Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent are excluded, even if they have a legal representative.
  • 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.
  • 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.
  • 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.
  • Use of SGLT2-i and GLP-1 agonist within 90 days prior to randomisation.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Australia13 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland

  • Bundaberg Hospital

    Bundaberg, Queensland

  • Cairns Hospital

    Cairns, Queensland

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • Canberra Hospital

    Garran, Australian Capital Territory

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Logan Hospital

    Logan City, Queensland

  • Mackay Base Hospital

    Mackay, Queensland

  • Fiona Stanley Hospital

    Murdoch, Western Australia

  • Rockhampton Hospital

    Rockhampton, Queensland

  • Mater Hospital

    South Brisbane, Queensland

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

About this study

Official title: International, Multi-centre Randomised Clinical Trial of Obinutuzumab Versus Corticosteroid and Cyclophosphamide in Primary Membranous Nephropathy (REMIT Trial).

REMIT is an investigator-initiated, international, multi-centre, prospective, randomised, open-label, parallel-group trial. A total of 224 adult participants with Primary Membranous Nephropathy (PMN) will be recruited from renal units from Australia, New Zealand Canada, Asia, Europe, United Kingdom, and other countries. Participants will be randomised to receive either corticosteroid and cyclophosphamide or obinutuzumab. The primary outcome is a ranked, composite measure based on (a) efficacy, defined as either complete or partial remission of PMN, (b) number of adverse events, and (c) quality of life.

Being tested
Obinutuzumab, Oral prednisolone and cyclophosphamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Participants will receive an intravenous infusion of 1,000mg Obinutuzumab at Weeks 0, 2, 24 and 26.

    Prior to the administration of obinutuzumab, the participant will receive pre-medications consisting of all three:

    • IV methylprednisolone 80 mg,
    • Paracetamol 1,000 mg orally,
    • Either cetirizine 10 mg orally or diphenhydramine 50 mg orally. These pre-medications must be completed between 30 to 60 minutes prior to the obinutuzumab infusion.

  • Oral prednisolone and cyclophosphamideDrug

    Participants will receive a combination of oral prednisolone and cyclophosphamide with 2 options (Option A and B).

    Option A: Cyclical prednisolone and cyclophosphamide with IV methylprednisolone

    • IV methylprednisolone 500-1000 mg will be given on days 1, 2 and 3 at the start of months 1, 3, and 5.
    • Oral prednisolone will be given at 0.5 mg/kg/day (max 50 mg/day) in months 1, 3, and 5.
    • Oral cyclophosphamide will be given in months 2, 4 and 6, adjusted by age and weight

    Option B: Concurrent prednisolone and cyclophosphamide without IV methylprednisolone

    • Oral prednisolone will be given to meet a cumulative dose equivalent to 0.5 mg/kg/day for 90 days (max 50 mg/day).
    • Oral cyclophosphamide will be given for 90 days, adjusted by age and weight
Study groups in NCT06120673
Study groupRoleWhat they receive
ObinutuzumabExperimentalNot described
Receives: Drug: Obinutuzumab
Oral prednisolone and cyclophosphamideActive comparatorNot described
Receives: Drug: Oral prednisolone and cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A ranked composite measure based efficacy, safety and quality of life at 24 months

    A ranked composite measure comprising of:

    1. Efficacy (complete/partial remission) plus safety (type of adverse event) at 24 months
    2. Number of adverse events up to 24 months
    3. Quality of Life (EQ-5D) averaged over 24 months

    Measured: 24 months

Secondary outcomes (15)

  1. Number of participants in Complete Remission (CR)

    Number of participants who have proteinuria of ≤3.0 g/day

    Measured: At 6, 12, 18, 24 month

  2. Number of participants in Partial Remission (PR)

    Number of participants who have proteinuria of between >3.0 and 3.5 g/day and >50% reduction from baseline proteinuria

    Measured: At 6, 12, 18, 24 month

  3. Number of participants in CR and/or PR

    Number of participants who meet complete and/or partial PMN remission definition

    Measured: At 6, 12, 18, 24 month

  4. Number of non-serious adverse events of special interest

    Number of protocol defined non-serious events of special interest (related to PMN or the study interventions)

    Measured: Up until 24 months

  5. Number of serious adverse events

    Number of protocol defined serious adverse events

    Measured: Up until 24 months

  6. Number of participants with a lack of response to PMN treatment

    Number of participants who have <50% reduction in proteinuria from baseline or worsening (increasing in value from baseline) proteinuria, and had not achieved either PR or CR

    Measured: Up until 24 months

  7. Number of participants who relapse after CR or PR

    Number of participant who have a reappearance of proteinuria to >3.5 g/day at a ≥50% higher level than the lowest post-treatment value in participants who had previously achieved either PR or CR

    Measured: Up until 24 months

  8. Time to first relapse

    The time to relapse is the time interval from the last point in time when the participant was in the best remission status (either PR or CR) to the first relapse

    Measured: Up until 24 months

  9. Number of participants who have immunological remission (for anti-PLA2R positive participants)

    Number of participants who have their anti-PLA2R-Ab level drop below 2 RU/mL who are ≥14 RU/ml at baseline

    Measured: Up until 24 months

  10. Number of participants who have a requirement for rescue therapy

    Number of participants who have a lack of response or relapse at 12 months, and rescue therapies such as obinutuzumab, calcineurin inhibitors, or additional corticosteroid and cyclophosphamide are used.

    Measured: Up until 24 months

  11. Number of participants who exit the trial

    Number participant who cease trial follow-up for any reason

    Measured: Up until 24 months

  12. Quality of life scores (EQ-5D-5L)

    Quality of life scores using EQ-5D-5L

    Measured: at 3, 6, 9, 12, 15, 18, 24 months

  13. eGRF slope

    Change in eGFR slope

    Measured: Up until 24 months

  14. Number of treatment or PMN associated deaths

    Number of deaths attributed directly or indirectly to a complication of PMN or the treatment for PMN

    Measured: Up until 24 months

  15. All cause deaths

    Number of deaths of any cause

    Measured: Up until 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start31 Oct 2025 (estimated)
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Why it stopped: The study was deemed unfeasible due to unforeseen financial limitations

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120673
Sponsor's protocol ID
AKTN 18.03
Acronym
REMIT
Status last verified
Apr 2025
First submitted
12 Dec 2022
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sets will be made available to researchers within the REMIT Study for analysis of sub-studies and country specific outcomes after the primary manuscript has been accepted for publication. For researchers outside the REMIT study, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing and research team expertise. Where data linkage has been used to estimate health care services utilisation, data sharing will be determined by the specific requirements of the data custodians. In some circumstances it may not be possible to share participant level data beyond the country in which it was collected. This will be addressed on a jurisdiction basis.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obinutuzumab and Oral prednisolone and cyclophosphamide in people with Primary Membranous Nephropathy, run by The University of Queensland at 13 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A ranked composite measure based efficacy, safety and quality of life at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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