Tests ARGX-121 in adults with IgA nephropathy kidney disease
Tests ARGX-121 against placebo in adults with IgA nephropathy, a kidney disease.
Key facts
- Who runs it
- argenx
- Where
- Cracow, Poznan, and Szczecin, PolandSee the 4 sitesAlso in 6 other countries, 25 sites
- Trial code
- Registry title
- A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 120 people, planned
- Started
- 5 Nov 2026
- Expected to end
- 18 Feb 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ARGX-121
- Placebo
- Record updated
- 27 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with IgA nephropathy (IgAN) confirmed by a kidney biopsy. It tests ARGX-121 against placebo.
- Age
- At least 18 years old.
- Sex
- Men and women can join. Women must not be pregnant.
- Disease stage
- IgAN diagnosed by a doctor and confirmed by a biopsy. The record names no stage.
Main reasons for not taking part
- Another autoimmune disease or condition that makes it hard to judge IgAN symptoms
- IgAN caused by another disease (secondary IgAN)
- History of cancer
- Active infection of concern
- Recent major surgery or organ transplant
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Males and females (not pregnant)
- At least 18 years old
- Clinically diagnosed with IgAN with biopsy confirmation
Who cannot take part
- Recent Major surgery or organ transplant
- Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
- History of Malignancy
- Active infection of concern
- Has secondary form of IgAN leading to IgA deposits
Where in Poland
Also in 6 other countries, 25 sites
- Scm Sp. z o.o.Cracow, PolandTaking people
- Med Polonia Sp z o.o.Poznan, PolandTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
- Uniwersytecki Szpital Kliniczny Nr 2 PUM w SzczecinieSzczecin, PolandTaking people
About the trial
What the trial wants to find out
The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.
Read full original descriptionShow less
While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise.
The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.
The 2 groups in the trial
- ARGX-121Treatment being tested
Participants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks)
- Placebo followed by ARGX-121Placebo, for comparison
Participants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.
Treatment: ARGX-121 and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy
- Plain-language title
- Tests ARGX-121 in adults with IgA nephropathy kidney diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 27 October 2026