Actively Recruiting
A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)
Led by Jade Biosciences, Inc. · Updated on 2026-05-29
30
Participants Needed
7
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of JADE101 in adults aged 18 to 60 with Immunoglobulin A Nephropathy (IgAN). This open-label Phase 2 study aims to better understand how JADE101 works in this patient group and contribute to its overall clinical characterization. The study is sponsored by Jade Biosciences, Inc. Participants will receive JADE101 as a subcutaneous injection. The study does not include a placebo or comparator group and follows an open-label design where both researchers and participants know the treatment given. The treatment period and monitoring will extend up to 100 weeks to assess safety and kidney function effects. During the study, participants will attend scheduled visits for treatment and evaluation. Researchers will monitor treatment-emergent adverse events and measure urine protein creatinine ratio (UPCR) to assess kidney function. Participants must follow contraceptive and lifestyle requirements, comply with study visits, and complete laboratory tests. The total observation period spans from day 1 through 100 weeks, allowing long-term safety and efficacy assessment.
CONDITIONS
Brief Title
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18-60 years of age and able to legally consent
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2
- Biopsy-confirmed primary IgA Nephropathy
- Stable and maximally tolerated doses of ACE inhibitors or angiotensin receptor blockers for at least 12 weeks before screening
- Urine protein creatinine ratio (UPCR) of 0.75 g/g or higher
- Willing to provide written informed consent
- Able to comply with study visits, treatment, laboratory tests, and procedures
- Agree to contraceptive and lifestyle requirements
You will not qualify if you...
- Secondary forms of IgA Nephropathy
- Coexisting chronic kidney disease other than IgAN
- Known or suspected rapidly progressive glomerulonephritis
- Kidney biopsy showing other pathological conditions besides IgAN (except hypertensive vascular changes)
- Known or suspected primary or secondary immunodeficiency disorders
- Evidence of tuberculosis infection at screening
- Any chronic or acute infectious disease at screening
- History of bone marrow, hematologic stem cell, or solid organ transplantation
- Known or suspected alcohol or drug abuse
- Any clinically significant, unstable, or uncontrolled medical condition
- Malignancy within the past 5 years (except certain skin and cervical cancers)
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 100 weeks
Participants receive subcutaneous injections of JADE101 as the active treatment for IgA Nephropathy.
Regular visits for treatment and assessment throughout the 100-week period
Trial Site Locations
Total: 7 locations
1
Jade Clinical Site
Chula Vista, California, United States, 91910
Actively Recruiting
2
Jade Clinical Site
Arvada, Colorado, United States, 80002
Actively Recruiting
3
Jade Clinical Site
Denver, Colorado, United States, 80220
Actively Recruiting
4
Jade Clinical Site
Orlando, Florida, United States, 32806
Actively Recruiting
5
Jade Clinical Site
Pembroke Pines, Florida, United States, 33029
Actively Recruiting
6
Jade Clinical Site
Houston, Texas, United States, 77099
Actively Recruiting
7
Jade Clinical Site
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
J
JADE101 Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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