Immunoglobulin A Nephropathy (IgAN)Phase 2VerdantNCT07773727
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
A Phase 2 study testing ARGX-121 in people with Immunoglobulin A Nephropathy (IgAN), run by argenx at 11 sites in 2 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy (IgAN)
- What is being tested?
- ARGX-121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 5 Nov 2026to 18 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (not pregnant)
- At least 18 years old
- Clinically diagnosed with IgAN with biopsy confirmation
Who cannot join
- Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
- Has secondary form of IgAN leading to IgA deposits
- History of Malignancy
- Active infection of concern
- Recent Major surgery or organ transplant
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
857-350-4834, clinicaltrials@argenx.com
Biruh Workeneh, MD
- Not yet recruiting
Northwest Houston Arthritis Center - Houston
Houston, Texas, 77090-4328
+1 857-350-4834, clinicaltrials@argenx.com
Adnan Peer
- Recruiting
Kidney and Hypertension Specialists- Virginia
Manassas, Virginia, 20110
+1 857-350-4834, clinicaltrials@argenx.com
Rashida Rahman, MD
- Recruiting
Bioresearch Partners
Miami, Florida, 33127
+1 857-350-4834, clinicaltrials@argenx.com
Jose Miguel Cardona-Guzman, MD
- Recruiting
Nephrology Associates of South Miami PA
Miami, Florida, 33173-3456
+1 857-350-4834, clinicaltrials@argenx.com
Fernando Trespalacios, MD
- Recruiting
BioResearch Partner - Pembroke Pines
Pembroke Pines, Florida, 33029
857-350-4834, clinicaltrials@argenx.com
Max Benjamin, MD
- Recruiting
Michigan Kidney Consultants
Pontiac, Michigan, 48341
+1 857-350-4834, clinicaltrials@argenx.com
Fahd Al-Saghir, MD
- Recruiting
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
857-350-4834, clinicaltrials@argenx.com
Sanjiv Anand, MD, MS
- Recruiting
Amicis Research Center - Valencia
Valencia, California, 91355
857-350-4834, clinicaltrials@argenx.com
Billy Hour, MD
Japan2 sites, 2 recruiting
- Recruiting
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
+1 857-350-4834, clinicaltrials@argenx.com
Masanori Tokumoto, MD, PhD
- Recruiting
Sapporo City General Hospital
Sapporo, Hokkaidô
857-350-4834, clinicaltrials@argenx.com
Mamiko Shimamoto, MD
About this study
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
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.
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.
- Conditions
- Immunoglobulin A Nephropathy (IgAN)
- Being tested
- ARGX-121, Placebo
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-121Biological
Subcutaneous Injection of ARGX-121
PlaceboBiological
Subcutaneous Injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| ARGX-121 | Experimental | Participants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks) Receives: Biological: ARGX-121 |
| Placebo followed by ARGX-121 | Placebo comparator | 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. Receives: Biological: ARGX-121; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
UPCR is urine protein-to-creatinine ratio
Measured: Up to 24 weeks
Secondary outcomes (7)
Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52
Measured: 52 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 68 weeks
Cmax (ARGX-121 maximum observed concentration) in serum
Measured: Up to 68 weeks
Percentage change in total IgA from baseline over time in serum
Measured: Up to 68 weeks
Percentage change in Gd-IgA1 from baseline over time in serum
Gd-IgA1 means galactose-deficient immunoglobulin A1
Measured: Up to 68 weeks
Percentage change in total IgG from baseline over time in serum
Measured: Up to 68 weeks
Incidence of antidrug antibodies (ADA) against ARGX-121 in serum
Measured: Up to 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start5 Nov 2026 (estimated)
- Primary completion29 Oct 2029 (estimated)
- Study completion18 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773727
- Sponsor's protocol ID
- ARGX-121-26-IgAN-2001
- Other IDs
- 2026-525638-43-00
- Acronym
- Verdant
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07773727
- Acronym / sponsor ID
- Verdant / ARGX-121-26-IgAN-2001
- Conditions
- Immunoglobulin A Nephropathy (IgAN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 29 Oct 2029 (estimated)
- Study completion
- 18 Feb 2030 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARGX-121 | Experimental | Biological: ARGX-121Participants 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-121 | Placebo comparator | Biological: ARGX-121, Biological: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females (not pregnant)
- At least 18 years old
- Clinically diagnosed with IgAN with biopsy confirmation
Key exclusion criteria (5 listed)
- Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
- Has secondary form of IgAN leading to IgA deposits
- History of Malignancy
- Active infection of concern
- Recent Major surgery or organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-121Subcutaneous Injection of ARGX-121 | Biological | ARGX-121, Placebo followed by ARGX-121 |
| PlaceboSubcutaneous Injection of Placebo | Biological | Placebo followed by ARGX-121 |
Primary outcome
Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
Time frame: Up to 24 weeks
UPCR is urine protein-to-creatinine ratio
7 secondary outcomes
Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52
Time frame: 52 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 68 weeks
Cmax (ARGX-121 maximum observed concentration) in serum
Time frame: Up to 68 weeks
Percentage change in total IgA from baseline over time in serum
Time frame: Up to 68 weeks
Percentage change in Gd-IgA1 from baseline over time in serum
Time frame: Up to 68 weeks
Percentage change in total IgG from baseline over time in serum
Time frame: Up to 68 weeks
Incidence of antidrug antibodies (ADA) against ARGX-121 in serum
Time frame: Up to 68 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARGX-121 in people with Immunoglobulin A Nephropathy (IgAN), run by argenx at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, Clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection. (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.