Evaluating YK012 for treating primary membranous nephropathy
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Primary Membranous Nephropathy
This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Excyte Biopharma Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06982729 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of YK012 in patients diagnosed with primary membranous nephropathy. It consists of two phases: Phase Ia focuses on determining the maximum tolerated dose and recommended dose for expansion, while Phase Ib evaluates the preliminary efficacy of YK012 and establishes the recommended Phase II dose. Participants will undergo various assessments to monitor their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of primary membranous nephropathy and specific kidney function criteria.
Not a fit: Patients with secondary causes of membranous nephropathy or those not meeting the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from primary membranous nephropathy.
How similar studies have performed: While this approach is novel for this specific condition, similar studies evaluating new treatments for nephropathies have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 to 80 years (inclusive), regardless of gender. * Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years. * Elevated 24-hour urine protein, meeting the pre-defined criteria. * Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m² as calculated by the CKD-EPI equation. * If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy. * Laboratory test results must meet the predefined criteria within 7 days prior to enrollment. * Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures as required. Exclusion Criteria: * Diagnosis of secondary membranous nephropathy. * Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy. * History of malignancy within 5 years prior to enrollment. * Poorly controlled hypertension at enrollment. * Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment. * Prior kidney biopsy-confirmed diagnosis of diabetic nephropathy. * History of severe or chronic infections within the 6 months before enrollment or current need for systemic antibiotic or antiviral therapy. * Cardiovascular or cerebrovascular events requiring hospitalization within 6 months prior to enrollment. * Severe or poorly controlled comorbidities that may affect protocol compliance or efficacy evaluation. * Active Tuberculosis (TB) with documented evidence of infection. * History of solid organ or bone marrow transplantation. * Live vaccination, major surgery, or participated in other clinical trials with investigational drug use within 28 days prior to enrollment. * HBsAg-positive, or HBcAb-positive with detectable HBV DNA above the normal range; HCV antibody-positive; HIV seropositive; Treponema pallidum antibody-positive. * CD4+ T lymphocyte count \<200 cells/μL * Known hypersensitivity to any component of YK012. * Pregnancy, breastfeeding, or positive pregnancy test at screening; or plans to become pregnant during the trial or within 12 months after study completion, or unwillingness to use physical contraceptive methods during the study and for 12 months thereafter. * Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Minghui Zhao, M.D. — Peking University First Hospital
- Study coordinator: Minghui Zhao, M.D.
- Email: mhzhao@bjmu.edu.cn
- Phone: +86-010-83572388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.