This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy.
The study has two parts. Part one is dose escalation part, and Part two is dose expansion part.
The age range is between 18 and 80 years old, regardless of gender.
Diagnosed with primary membranous nephropathy by renal biopsy during the screening/induction period or within 24 months before screening. Pathological reports must be reviewed by the investigator prior to study drug administration.
The glomerular filtration rate (eGFR) estimated by CKD-EPI formula is ≥ 40ml/min/1.73m², or the endogenous creatinine clearance rate (CrCl) based on 24-hour urine examination is ≥ 40ml/min.
Participants taking angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists must maintain a stable dose for at least 4 weeks before screening;
Secondary membranous nephropathy.
Diagnostic renal biopsy shows evidence of glomerular crescent formation, which suggests the diagnosis of other renal diseases or renal biopsy evidence of interstitial fibrosis/tubular atrophy in cortical area > 50%.
Uncontrolled blood pressure as judged by the investigator within the 3 months prior to screening.
Individuals with evidence of a ≥50% decrease in urine protein within the first 6 months before screening.
Parallel
JMT601 Injection
DrugIn accordance with the protocol
Rituximab
DrugIn accordance with the protocol
Cyclosporin Capsules
DrugIn accordance with the protocol
Incidence of adverse events in Part 1
Overall Remission Rate at week 52 in Part 2
Participants with overall remission are those achieving either complete remission or partial remission
Blood drug concentration of JMT-601 in Part 1
Immunological remission in the anti-PLA2R antibody positive population in Part 1
Proportion of anti-PLA2R antibody-positive participants achieving immunological remission
Changes in anti-PLA2R antibody titers from baseline in anti-PLA2R antibody positive population in Part 1
Overall Remission Rate in Part 1
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
