IgA Nephropathy study: JADE101
Official title A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
ClinicalTrials.gov ID: NCT07902817
What this study is testing
What is JADE101?
JADE101 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for iga nephropathy (igan).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out whether JADE101 is safe and works better than a placebo in adults with IgA nephropathy.
- Who it's for
- Adults who have been diagnosed with IgA nephropathy.
- What's involved
- Participants will be randomly given either JADE101 or a placebo and will undergo regular check‑ups and tests to monitor safety and kidney function.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Body weight \<40 kg or morbid obesity.
- Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal...
- Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy.
See the full eligibility criteria
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Arvada, Colorado, United States
- Lauderdale Lakes, Florida, United States
- Atlanta, Georgia, United States
- Katy, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Arvada, Colorado, United States; Lauderdale Lakes, Florida, United States; Atlanta, Georgia, United States; Katy, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.