Testing MIL62 for treating Primary Membranous Nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and efficacy of MIL62 in patients with Primary Membranous Nephropathy (pMN) through two phases. In Phase Ib, 30 subjects are randomly assigned to receive either MIL62 at doses of 600mg or 1000mg, or cyclosporine, with safety assessed over four weeks. If deemed tolerable, Phase II will further assess the efficacy of these treatments over a total of 104 weeks, focusing on the overall response rate at 76 weeks as the primary endpoint.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients, ≥18 years of age;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
3. Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein \> 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
4. eGFR ≥40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m\^2 based on 24-hour urine collection during screening；
5. Sufficient organ function;
6. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Participants with a secondary cause of MN；
2. Cyclosporine resistance；
3. Urine protein decreased by \> 50% within 6 months before screening；
4. Received treatment drugs for membranous nephropathy；
5. Concomitant with other serious diseases；
6. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
9. Other exclusion criteria may apply；

Where it's running

• Peking University First Hospital
  Beijing, Beijing, China Recruiting

Study contacts

• Study coordinator: Minghui Zhao, doctor
• Email: mhzhao@bjmu.edu.cn
• Phone: 8610-83572388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SHR-2173 injections for adults with primary membranous nephropathy

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• Povetacicept for people with primary membranous nephropathy

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• ALXN1920 for adults with primary membranous nephropathy

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• Budoprutug for primary membranous nephropathy (Phase 2)

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• Evaluating YK012 for treating primary membranous nephropathy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.