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Recruiting NCT07541287

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

Phase II Interventional IgA Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JADE101.
Who it may be relevant to
Registry conditions: IgA Nephropathy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, New Zealand, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)

Overview

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.

Interventions

  • Drug JADE101
    JADE101 is supplied as sterile solution to be administered by SC injection

Primary outcome measures

  • Incidence of treatment-emergent adverse events (safety and tolerability) [Time frame: Day 1 through 100 weeks]
Secondary outcome measures (1)
  • Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy [Time frame: Day 1 through 100 weeks]

Eligibility criteria

Inclusion 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 dose or discontinue treatment, unless medically necessary
  • 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

Exclusion criteria

  • 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); hypertensive vascular changes are acceptable
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Jade Clinical Site — Chula Vista
  • Jade Clinical Site — Arvada
  • Jade Clinical Site — Denver
  • Jade Clinical Site — Orlando
  • Jade Clinical Site — Pembroke Pines
  • Jade Clinical Site — Houston
South Korea · 2 centers
  • Jade Clinical Site — Seoul
  • Jade Clinical Site — Seoul
New Zealand · 1 center
  • Jade Clinical Site — Christchurch

Identifiers

NCT: NCT07541287 · JADE101-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗