New hope for kidney disease: experimental drug targets protein leak
NCT ID NCT06454110
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a drug called NM8074 in 10 adults with IgA Nephropathy, a kidney disease that can lead to kidney failure. The goal is to see if the drug safely reduces protein in the urine, a sign of kidney damage, after 99 days of treatment. Participants must have a recent kidney biopsy confirming the disease and receive required vaccinations before starting.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2028
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 10,000 kidneys under the microscope: registry maps IgA Nephropathy's course
- Microbes in the mouth and gut may hold clues to a common kidney disease
- Can a transplant drug tame stubborn kidney disease?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?
- Can a new injection slow kidney disease in children?