Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN) (NCT06454110) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)
10 participantsStarted 2028-02
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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:
* 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 s…
What they're measuring
1
Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio