BridgeMD
Tests treatment safety and results for Minimal Change Disease (MCD)
Official title Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
ClinicalTrials.gov ID: NCT07614477
What this study is testing
What is EVER001?
EVER001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for minimal change disease (mcd).
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 is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes).
- 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 75
You may be able to join if
- Primary FSGS or MCD/IgAN confirmed by renal biopsy
- eGFR ≥ 45 mL/min/1.73 m²
- For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \> 3.5 g/g and serum albumin \< 30 g/L during the...
- For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
- Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment
You likely can't join if
- Hereditary or secondary FSGS/MCD; collapsing FSGS
- BMI ≥ 35 kg/m² in participants with FSGS/MCD
- Evidence of diabetes mellitus or a history of diabetes mellitus
- Acute or chronic infection requiring treatment
- Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
- Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
See the full eligibility criteria
- Primary FSGS or MCD/IgAN confirmed by renal biopsy
- eGFR ≥ 45 mL/min/1.73 m²
- For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \> 3.5 g/g and serum albumin \< 30 g/L during the screening period
- For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
- Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment
- Hereditary or secondary FSGS/MCD; collapsing FSGS
- BMI ≥ 35 kg/m² in participants with FSGS/MCD
- Evidence of diabetes mellitus or a history of diabetes mellitus
- Acute or chronic infection requiring treatment
- Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
- Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
- At risk of bleeding
- Baseline 24-hour UPCR \> 3 g/g and serum albumin \< 30 g/L in participants with IgAN
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Tianjin, Hebei, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Tianjin, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.