ClinicalTrials.gg
RecruitingNCT07541287Updated Oct 30, 2026

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

A Phase 2 interventional study of JADE101 in IgA Nephropathy, sponsored by Jade Biosciences, Inc.. Recruiting at 22 sites in 5 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Jade Biosciences, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 30, 20268 sites added1 site removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.

02

Conditions studied

  • IgA Nephropathy

Keywords

  • Glomerulonephritis
  • Nephritis
  • Nephropathy
  • Kidney Diseases
  • Urologic Diseases
  • Urogenital Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Proteinuria
  • Glomerulonephritis, IGA
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 30 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Jade Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the
  2. ≥ 30 mL/min/1.73 m2
  3. -confirmed primary IgAN
  4. Receiving stable and maximally tolerated doses of either ACEi or ARB as per standard of care (SoC) and applicable guidelines for at least 12 weeks prior to the initial screening visit, with no intention to alter the dose or discontinue treatment, unless medically necessary
  5. UPCR ≥ 0.75 g/g
  6. Willing to provide written informed consent
  7. Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures
  8. Willing and able to comply with and lifestyle requirements

Exclusion criteria

Exclusion Criteria:

  1. Secondary forms of IgAN
  2. Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
  3. Known or suspected rapidly progressive glomerulonephritis (RPGN)
  4. Evidence of pathological findings in the kidney in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); hypertensive vascular changes are acceptable
  5. Known or suspected primary or secondary immunodeficiency disorder
  6. Evidence of tuberculosis infection at screening
  7. Any chronic infectious disease
  8. Any acute infectious disease at time of screening
  9. Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney
  10. Known or suspected alcohol or drug abuse
  11. Any and/or unstable or uncontrolled medical condition as assessed by the investigator
  12. within the past 5 years; nonmelanoma skin cancer and curatively treated cervical carcinoma in situ are allowed

Other protocol-defined inclusion/exclusion criteria may apply

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    JADE101

    Subcutaneous (SC) injection of JADE101

    Drug: JADE101

Interventions

  • JADE101 is supplied as sterile solution to be administered by SC injection

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (safety and tolerability)

    The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug

    Time frame: Day 1 through 100 weeks

Secondary outcomes

  1. Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy

    Change from baseline in UPCR

    Time frame: Day 1 through 100 weeks

07

Study locations

22 of 22 sites recruiting
  • Jade Clinical Site
    Chula Vista, California 91910, United States
    Recruiting
  • Jade Clinical Site
    Arvada, Colorado 80002, United States
    Recruiting
  • Jade Clinical Site
    Denver, Colorado 80220, United States
    Recruiting
  • Jade Clinical Site
    Orlando, Florida 32806, United States
    Recruiting
  • Jade Clinical Site
    Pembroke Pines, Florida 33029, United States
    Recruiting
  • Jade Clinical Site
    Houston, Texas 77099, United States
    Recruiting
  • Jade Clinical Site
    Concord, New South Wales 2138, Australia
    Recruiting
  • Jade Clinical Site
    Liverpool, New South Wales 2170, Australia
    Recruiting
  • Jade Clinical Site
    Parkville, Victoria 3050, Australia
    Recruiting
  • Jade Clinical Site
    Christchurch, 8011, New Zealand
    Recruiting
  • Jade Clinical Site
    Anyang-si, 14068, South Korea
    Recruiting
  • Jade Clinical Site
    Seongnam-si, 13620, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 03080, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 03722, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 06351, South Korea
    Recruiting
  • Jade Clinical Site
    Suwon, 16499, South Korea
    Recruiting
  • Jade Clinical Site
    Kaohsiung City, Kaohsiung 833401, Taiwan
    Recruiting
  • Jade Clinical Site
    Taichung, Taichung 404327, Taiwan
    Recruiting
  • Jade Clinical Site
    New Taipei City, Taipei 235041, Taiwan
    Recruiting
  • Jade Clinical Site
    Taipei City, Taipei 110301, Taiwan
    Recruiting
  • Jade Clinical Site
    Taipei, Taipei 100225, Taiwan
    Recruiting
  • Jade Clinical Site
    Taiyuan, Taoyuan 333423, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jan 2029, 32 months after the start.

Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 32 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 21, 2026
StartActual
May 19, 2026
Primary completionEst.
Jan 2029
CompletionEst.
Apr 2029
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
8 sites added, 1 site removed
Show 8 added (6 Taiwan, 2 Australia)
  • Jade Clinical Site · Liverpool, Australia
  • Jade Clinical Site · Parkville, Australia
  • Jade Clinical Site · Taichung, Taiwan
  • Jade Clinical Site · New Taipei City, Taiwan
  • Jade Clinical Site · Taipei City, Taiwan
  • Jade Clinical Site · Taipei, Taiwan
  • Jade Clinical Site · Kaohsiung City, Taiwan
  • Jade Clinical Site · Taiyuan, Taiwan
Show 1 removed
  • Jade Clinical Site · Taipei, Taiwan
across 2 updates, Sep 25, 2026 – Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    2 sites added
    Show 2 added (2 Taiwan)
    • Jade Clinical Site · Kaohsiung City, Taiwan
    • Jade Clinical Site · Taiyuan, Taiwan
    + 1 other change: verification date
  2. Sep 25, 2026
    6 sites added, 1 site removed
    Show 6 added (4 Taiwan, 2 Australia)
    • Jade Clinical Site · Liverpool, Australia
    • Jade Clinical Site · Parkville, Australia
    • Jade Clinical Site · Taichung, Taiwan
    • Jade Clinical Site · New Taipei City, Taiwan
    • Jade Clinical Site · Taipei City, Taiwan
    • Jade Clinical Site · Taipei, Taiwan
    Show 1 removed
    • Jade Clinical Site · Taipei, Taiwan
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07541287
Lead sponsor
Jade Biosciences, Inc.
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
May 19, 2026
Primary completion
Jan 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

JADE101 Study Contact
Contact
JADE101clinicaltrials@jadebiosciences.com
+1 781 201 4703
Li Li, MD
study director · Jade BioSciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: JADE101

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