JADE101 in IgA Nephropathy (phase 3, blinded)

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

In this randomized, blinded phase 3 trial, adults with biopsy-confirmed IgA nephropathy and certain levels of protein in the urine will receive JADE101 or placebo while continuing standard kidney-protective care. The study will assess safety and whether JADE101 reduces protein excretion and preserves kidney function. Participants must have stable ACEi/ARB therapy and meet specific kidney function and weight criteria. Multiple U.S. sites are enrolling to evaluate the treatment in a real-world care context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult participants with biopsy-confirmed primary IgAN.
2. UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample.
3. eGFR ≥30 mL/min/1.73 m².
4. 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.

Exclusion Criteria:

1. Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment.
2. Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
3. Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).
4. Body weight \<40 kg or morbid obesity.
5. Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
6. Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy.

   1. Anti-APRIL biologics
   2. Anti-CD38 therapy
   3. Anti-CD20 therapy
7. Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening.
8. Presence of or history of nephrotic syndrome, defined as 24-hour urine protein \>3.5 g/day with concurrent hypoalbuminemia.
9. Serum IgG level \<6 g/L (\<600 mg/dL).

Other protocol-defined inclusion and exclusion criteria may apply.

Where it's running

• Jade Clinical Site
  Arvada, Colorado, United States Recruiting
• Jade Clinical Site
  Lauderdale Lakes, Florida, United States Recruiting
• Jade Clinical Site
  Atlanta, Georgia, United States Recruiting
• Jade Clinical Site
  Katy, Texas, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.