Study of NM8074 in Adult C3 Glomerulopathy Patients (NCT05647811) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of NM8074 in Adult C3 Glomerulopathy Patients
18 participantsStarted 2027-05
Plain-language summary
This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 and ≤ 65 years at the time of consent
* Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment
* Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening
* Patients with confirmed proteinuria
* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug
* Males must agree to use contraceptives and refrain from donating sperm for the duration of the study
* Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.
* Estimated glomerular filtration (eGFR) rate of ≤ 60 ml/min but ≥ 20 ml/min
Exclusion Criteria:
* Use of other investigational drugs at the time of enrollment
* Patients with other renal diseases that would interfere with interpretation of the st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Monitoring for incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Timeframe: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
2
Change from Baseline or Percent Change from Baseline in Urine Protein to Creatine Concentration Ratio (UPCR)
Timeframe: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
3
Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR)
Timeframe: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
4
Ratio to Baseline of UPCR and UACR
Timeframe: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
5
Change from Baseline or Percent Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timeframe: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3