A Phase 2 interventional study of NM8074 in IgA Nephropathy, sponsored by NovelMed Therapeutics. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by NovelMed Therapeutics · Phase 2, Interventional, and Treatment
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This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.
The proposed study, NM8074-IgAN-601, will enroll a planned total of 10 patients as subjects for the trial. All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.
276 studies on the registry are indexed under Glomerulonephritis, IGA; 108 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →NovelMed Therapeutics is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.
Drug: NM8074
NM8074 will be administered as an intravenous infusion. All subjects will be administered 17 mg/kg of NM8074 intravenously weekly for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.
Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio
Time frame: Up to Study Day 99
Change from Baseline or Percent Change from Baseline in eGFR
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Serum Creatinine
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Hematuria
Measured through red blood cells present in urine from urinalysis
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine concentration ratio
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Bb plasma levels
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in sC5b-9 plasma levels
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in UPCR
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Tmax
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Cmax
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline AUC0-t
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in CLr
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in quality of life (QoL) Assessed via the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, Version 4.
The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale ranging from "Not at all" to "Very much so". All items are summed to create a single fatigue score with a range from 0 to 52 with a better quality of life indicated by a higher score.
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in Quality of Life (QoL) Assessed via the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Scale (QLQ- C30), Version 3.0
All EORTC QLQ-C30 scales and single-item measures range from 0 to 100. This includes 3 symptom scales (fatigue, pain, nausea and vomiting), 5 functional scales (physical, role, cognitive, emotional, and social), single-item questions addressing symptoms like insomnia, dyspnea, loss of appetite, and others that are commonly reported by cancer patients, and the perceived financial impact of the disease. A higher score is associated with a greater quality of life for global health status
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in Classical Pathway (CP) modulation
NM8074-mediated CP inhibition is measure via a complement CP ELISA-based assay measuring MAC formation.
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Factor B levels
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in plasma concentration of NM8074
Time frame: Up to Study Day 155
Maximum plasma concentration (Cmax)
Time frame: Up to Study Day 155
Time corresponding to Cmax (tmax)
Time frame: Up to Study Day 155
Area under the drug concentration-time curves (AUC0-t)
Time frame: Up to Study Day 155
No study locations are listed for this record.
Plan to share: No
Start is estimated for Feb 2028; primary completion for Dec 2030, 34 months later.
Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 34 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ruxoprubart
NovelMed Therapeutics