JADE101 in IgA Nephropathy: a Phase 2 test in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, Phase 2 trial evaluating JADE101 in adults with biopsy-confirmed IgA nephropathy. Eligible participants must have stable ACE inhibitor or ARB therapy for at least 12 weeks, an estimated GFR of at least 30 mL/min/1.73 m2, and a UPC of 0.75 g/g or higher. The study will monitor safety and efficacy outcomes to better characterize JADE101 in this patient population. Participating sites are in Chula Vista, CA, and Arvada and Denver, Colorado. The lead sponsor is Jade Biosciences, Inc., with no listed collaborators.

Why it matters

Who can join: the full rules

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 informed consent
2. eGFR ≥ 30 mL/min/1.73 m2
3. Biopsy-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 contraceptive and lifestyle requirements

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 biopsy 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 clinically significant and/or unstable or uncontrolled medical condition as assessed by the investigator
12. Malignancy 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

Where it's running

• Jade Clinical Site
  Chula Vista, California, United States Recruiting
• Jade Clinical Site
  Arvada, Colorado, United States Recruiting
• Jade Clinical Site
  Denver, Colorado, United States Recruiting
• Jade Clinical Site
  Orlando, Florida, United States Recruiting
• Jade Clinical Site
  Pembroke Pines, Florida, United States Recruiting
• Jade Clinical Site
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: JADE101 Study Contact
• Email: JADE101clinicaltrials@jadebiosciences.com
• Phone: +1 781 201 4703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.