NCT06454110Not yet recruitingPhase 2
Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)
A Phase II, Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- Feb 2028
- Primary completion date
- Dec 2030
- Lead sponsor
- NovelMed Therapeutics
- Diseases
- IgA nephropathy
- NCT number
- NCT06454110
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From Feb 2028 to the primary completion date, Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Require dialysis or plasma exchange within 12 weeks prior to screening.
- 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).
- 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.
Other illness
- Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.
- History of bone marrow, hematopoietic stem cells, or solid organ transplantation.
- 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.
Other
- Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.
- Clinically significant abnormal ECG during screening.
- Pregnant, planning to become pregnant, or nursing female subjects.
- Females with a positive pregnancy test result at Screening or on Day 1.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.