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Not yet recruitingNCT06454110Updated Apr 13, 2026

Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

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

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • IgA Nephropathy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female patients ≥18 years of age at the time of consent.
  • A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
  • Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years.
  • All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines.
  • Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3
  • Female and male participates must agree to use contraceptives

Exclusion criteria

Exclusion Criteria:

  • Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.
  • Require dialysis or plasma exchange within 12 weeks prior to screening.
  • Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.
  • History of bone marrow, hematopoietic stem cells, or solid organ transplantation.
  • Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer.
  • Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis).
  • Clinically significant abnormal ECG during screening.
  • Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
  • Has a currently active or known history of meningococcal disease or N. meningitidis infection.
  • Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.
  • Pregnant, planning to become pregnant, or nursing female subjects.
  • Females with a positive pregnancy test result at Screening or on Day 1.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    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

Interventions

  • DrugNM8074

    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.

05

What researchers measure

Primary outcomes

  1. Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio

    Time frame: Up to Study Day 99

Secondary outcomes

  1. Change from Baseline or Percent Change from Baseline in eGFR

    Time frame: Up to Study Day 155

  2. Change from Baseline or Percent Change from Baseline in Serum Creatinine

    Time frame: Up to Study Day 155

  3. 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

  4. Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine concentration ratio

    Time frame: Up to Study Day 155

  5. Change from Baseline or Percent Change from Baseline in Bb plasma levels

    Time frame: Up to Study Day 155

  6. Change from Baseline or Percent Change from Baseline in sC5b-9 plasma levels

    Time frame: Up to Study Day 155

  7. Change from Baseline or Percent Change from Baseline in UPCR

    Time frame: Up to Study Day 155

  8. Change from Baseline or Percent Change from Baseline in Tmax

    Time frame: Up to Study Day 155

  9. Change from Baseline or Percent Change from Baseline in Cmax

    Time frame: Up to study Day 155

  10. Change from Baseline or Percent Change from Baseline AUC0-t

    Time frame: Up to study Day 155

  11. Change from Baseline or Percent Change from Baseline in CLr

    Time frame: Up to study Day 155

  12. 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

  13. 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

Other outcomes

  1. 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

  2. Change from Baseline or Percent Change from Baseline in Factor B levels

    Time frame: Up to Study Day 155

  3. Change from Baseline or Percent Change from Baseline in plasma concentration of NM8074

    Time frame: Up to Study Day 155

  4. Maximum plasma concentration (Cmax)

    Time frame: Up to Study Day 155

  5. Time corresponding to Cmax (tmax)

    Time frame: Up to Study Day 155

  6. Area under the drug concentration-time curves (AUC0-t)

    Time frame: Up to Study Day 155

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Kim SJ, Koo HM, Lim BJ, Oh HJ, Yoo DE, Shin DH, Lee MJ, Doh FM, Park JT, Yoo TH, Kang SW, Choi KH, Jeong HJ, Han SH. Decreased circulating C3 levels and mesangial C3 deposition predict renal outcome in patients with IgA nephropathy. PLoS One. 2012;7(7):e40495. doi: 10.1371/journal.pone.0040495. Epub 2012 Jul 6. PubMed 22792353 ↗
  • Lafayette RA, Kelepouris E. Immunoglobulin A Nephropathy: Advances in Understanding of Pathogenesis and Treatment. Am J Nephrol. 2018;47 Suppl 1:43-52. doi: 10.1159/000481636. Epub 2018 May 31. PubMed 29852501 ↗
  • Duval A, Caillard S, Fremeaux-Bacchi V. The complement system in IgAN: mechanistic context for therapeutic opportunities. Nephrol Dial Transplant. 2023 Nov 30;38(12):2685-2693. doi: 10.1093/ndt/gfad140. PubMed 37385820 ↗
  • Medjeral-Thomas NR, Cook HT, Pickering MC. Complement activation in IgA nephropathy. Semin Immunopathol. 2021 Oct;43(5):679-690. doi: 10.1007/s00281-021-00882-9. Epub 2021 Aug 11. PubMed 34379175 ↗
  • Stefan G, Jullien P, Masson I, Alamartine E, Mariat C, Maillard N. Circulating alternative pathway complement cleavage factor Bb is associated with vascular lesions and outcomes in IgA nephropathy. Nephrol Dial Transplant. 2023 Nov 8;38(Suppl 2):ii11-ii18. doi: 10.1093/ndt/gfad163. PubMed 37816675 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06454110
Lead sponsor
NovelMed Therapeutics
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Feb 2028 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2031 (estimated)
Last update
Apr 13, 2026

Study contacts

Rekha Bansal, PhD
Contact
clinicalsae@novelmed.com
2164402696

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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