NCT07889362Not yet recruitingPhase 2
A Study to Learn About the Effects of Felzartamab on the Kidneys of Adults With Immunoglobulin A Nephropathy (IgAN)
A Phase 2 Open Label Study to Evaluate the Effects of Felzartamab on the Kidney in Individuals With IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. The main goal of the study is to learn about the effect felzartamab has on the buildup of IgA clusters in the kidneys. The main question that researchers want to answer is: • How much does the buildup of IgA in the kidney change from the start of the study to Week 36? Researchers will also learn about the effect felzartamab has on kidney health by measuring protein levels in the urine and the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how the body processes the drug. The study will be done as follows: * Participants will be screened to check if they can join the study. * This is an open-label study, which means both the researchers and the participants will know that all participants are receiving felzartamab. * Participants will receive felzartamab as intravenous (IV) infusions. * Participants will have kidney biopsies done over the course of the study to help measure changes in the health of the kidneys. * Participants will have multiple scheduled study visits over about 104 weeks. An extra study visit may be needed if a participant decides to leave the study early. * In total, participants will stay in the study for about 2 years (up to 112 weeks).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 16 Nov 2026
- Primary completion date
- 13 Aug 2028
- Lead sponsor
- Biogen
- Diseases
- IgA nephropathy
- NCT number
- NCT07889362
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 16 Nov 2026 to the primary completion date, 13 Aug 2028
- 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
- History of major surgery, severe trauma, or bone fracture within 3 months prior to first dose of felzartamab or planned major surgery any time from Screening until 1 month after the end of study.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Other illness
- Conditions that may predispose to an increased bleeding risk, as determined by the Investigator.
- History of diabetes mellitus.
- Any history of malignancy within 5 years prior to Screening with the exception of adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or other non-melanomatous skin cancer.
- Any clinically significant underlying illness that, in the opinion of the Investigator, medical monitor, and/or Sponsor may compromise study participation, present a safety risk to the participant, or may confound the interpretation of the study results, including general non-adherence to study medication therapy.
- Active clinically significant infections; known history of recurrent clinically significant infection.
Other
- Any diagnosed or suspected immunosuppressed or immunodeficient state.
- Hematologic and hepatic abnormalities.
Who the study is looking for
- Biopsy-confirmed diagnosis of IgAN.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.