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New treatment option for IgA Nephropathy
Official title A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
ClinicalTrials.gov ID: NCT07541287
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.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent
- eGFR ≥ 30 mL/min/1.73 m2
- Biopsy-confirmed primary IgAN
- 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...
- UPCR ≥ 0.75 g/g
You likely can't join if
- Secondary forms of IgAN
- Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
- Known or suspected rapidly progressive glomerulonephritis (RPGN)
- Evidence of pathological findings in the kidney biopsy in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous...
- Known or suspected primary or secondary immunodeficiency disorder
- Evidence of tuberculosis infection at screening
See the full eligibility criteria
- Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent
- eGFR ≥ 30 mL/min/1.73 m2
- Biopsy-confirmed primary IgAN
- 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...
- UPCR ≥ 0.75 g/g
- Willing to provide written informed consent
- Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures
- Willing and able to comply with contraceptive and lifestyle requirements
- Secondary forms of IgAN
- Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
- Known or suspected rapidly progressive glomerulonephritis (RPGN)
- 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)...
- Known or suspected primary or secondary immunodeficiency disorder
- Evidence of tuberculosis infection at screening
- Any chronic infectious disease
- Any acute infectious disease at time of screening
- Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney
- Known or suspected alcohol or drug abuse
- Any clinically significant and/or unstable or uncontrolled medical condition as assessed by the investigator
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Arvada, Colorado, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Pembroke Pines, Florida, United States
- Houston, Texas, United States
- Christchurch, New Zealand
- Seoul, South Korea
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 - 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 to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Arvada, Colorado, United States; Denver, Colorado, United States; Orlando, Florida, United States; Pembroke Pines, Florida, United States; Houston, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.