IgA Nephropathy (IgAN)Phase 3NCT07902817
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
A Phase 3 study testing JADE101 in people with IgA Nephropathy (IgAN), run by Jade Biosciences, Inc. at 4 sites in United States.
Trial summary
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN). The results will contribute to the overall clinical characterization of JADE101 in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- JADE101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2026to Sep 2030
- Phase
- Phase 3
- 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
- Adult participants with biopsy-confirmed primary IgAN.
- UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample.
- eGFR ≥30 mL/min/1.73 m².
- Stable and maximally tolerated doses of ACEi and/or ARB according to standard of care and applicable guidelines for at least 12 weeks prior to the initial screening visit.
Who cannot join
- Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment.
- Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
- Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).
- Body weight <40 kg or morbid obesity.
- Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
- Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy.
Show all 13Show fewer
- Anti-APRIL biologics
- Anti-CD38 therapy
- Anti-CD20 therapy
- Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Presence of or history of nephrotic syndrome, defined as 24-hour urine protein >3.5 g/day with concurrent hypoalbuminemia.
- Serum IgG level <6 g/L (<600 mg/dL).
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Jade Clinical Site
Arvada, Colorado, 80002
- Recruiting
Jade Clinical Site
Atlanta, Georgia, 30342
- Recruiting
Jade Clinical Site
Katy, Texas, 77494
- Recruiting
Jade Clinical Site
Lauderdale Lakes, Florida, 33313
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of JADE101 Administered Subcutaneously in Participants With Immunoglobulin A Nephropathy (The EVERGREEN Study)
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN). The results will contribute to the overall clinical characterization of JADE101 in this patient population.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- JADE101, Placebo
- Keywords
- Glomerulonephritis, Nephritis, Nephropathy, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases, Proteinuria, Glomerulonephritis, IGA
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulonephritis, Nephritis, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADE101Drug
JADE101 is supplied as sterile solution to be administered by SC injection.
PlaceboDrug
Placebo is supplied as sterile solution to be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| JADE101 Q8W | Experimental | Subcutaneous (SC) injection of JADE101 with Q8W maintenance dosing Receives: Drug: JADE101 |
| JADE101 Q12W | Experimental | Subcutaneous (SC) injection of JADE101 with Q12W maintenance dosing Receives: Drug: JADE101 |
| Placebo | Placebo comparator | Subcutaneous (SC) injection of placebo during the placebo-controlled treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Change from baseline in UPCR
Measured: Week 52
Secondary outcomes (1)
To evaluate the effect of JADE101 on Estimated Glomerular Filtration Rate (eGFR) in participants with IgA nephropathy
Change from baseline in eGFR
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jade Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Study director, Jade Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902817
- Sponsor's protocol ID
- JADE101-03
- Other IDs
- 2026-527177-11-00
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of JADE101 Administered Subcutaneously in Participants With Immunoglobulin A Nephropathy (The EVERGREEN Study)
- ClinicalTrials.gov ID
- NCT07902817
- Acronym / sponsor ID
- JADE101-03
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- Glomerulonephritis, Nephritis, Nephropathy, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jade Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 29 Oct 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.
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN). The results will contribute to the overall clinical characterization of JADE101 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JADE101 Q8W | Experimental | Drug: JADE101Subcutaneous (SC) injection of JADE101 with Q8W maintenance dosing |
| JADE101 Q12W | Experimental | Drug: JADE101Subcutaneous (SC) injection of JADE101 with Q12W maintenance dosing |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous (SC) injection of placebo during the placebo-controlled treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants with biopsy-confirmed primary IgAN.
- UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample.
- eGFR ≥30 mL/min/1.73 m².
- Stable and maximally tolerated doses of ACEi and/or ARB according to standard of care and applicable guidelines for at least 12 weeks prior to the initial screening visit.
Key exclusion criteria (13 listed)
- Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment.
- Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
- Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).
- Body weight <40 kg or morbid obesity.
- Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
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 |
|---|---|---|
| JADE101JADE101 is supplied as sterile solution to be administered by SC injection. | Drug | JADE101 Q12W, JADE101 Q8W |
| PlaceboPlacebo is supplied as sterile solution to be administered by SC injection. | Drug | Placebo |
Primary outcome
To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Time frame: Week 52
Change from baseline in UPCR
1 secondary outcome
To evaluate the effect of JADE101 on Estimated Glomerular Filtration Rate (eGFR) in participants with IgA nephropathy
Time frame: Week 52
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 3 Nov 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.
Li Li, MD study director
Jade Biosciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JADE101 in people with IgA Nephropathy (IgAN), run by Jade Biosciences, Inc. at 4 sites in United States.
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 4 inclusion and 13 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 JADE101 Study Contact (+1 781-201-4703, JADE101clinicaltrials@jadebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy (time frame: Week 52). 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 3 Nov 2026.