NCT07889362Toborzás még nem indult2. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 22.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 25 (tervezett)
- Első benyújtás
- 2026. okt. 16.
- Kezdés
- 2026. nov. 16.
- Elsődleges befejezés
- 2028. aug. 13.
- Fő szponzor
- Biogen
- Betegségek
- IgA-nefropátia
- NCT-szám
- NCT07889362
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 25
- 2026. nov. 16. és az elsődleges befejezés (2028. aug. 13.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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.
Egyéb
- Any diagnosed or suspected immunosuppressed or immunodeficient state.
- Hematologic and hepatic abnormalities.
Kiket keres a vizsgálat
- Biopsy-confirmed diagnosis of IgAN.
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