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

Launched by NOVELMED THERAPEUTICS · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NM8074 for patients with IgA Nephropathy, a kidney condition that can cause problems with protein in the urine. The goal of the study is to see if NM8074 can help reduce the amount of protein in the urine after 99 days of treatment. The trial is currently not recruiting participants, but when it starts, it will involve both men and women aged 18 and older who have been diagnosed with IgA Nephropathy through a kidney biopsy in the past three years.

To participate, patients need to meet certain criteria, such as having a body mass index (BMI) between 15 and 38 and being vaccinated against certain infections before starting the treatment. Participants will be expected to visit the study site regularly for evaluations and may need to follow specific guidelines regarding their health and medications during the trial. It’s important to note that individuals with certain health issues or infections, or who are pregnant or nursing, will not be eligible to join this study. This trial aims to contribute valuable information about how NM8074 might help people with this kidney condition.

Gender

ALL

Eligibility criteria

• 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 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.