Treatment of IgA Nephropathy with CM338

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 multicenter, randomized phase II clinical study evaluates the efficacy and safety of CM338 in patients with Immunoglobulin A nephropathy (IgAN). The study will also observe pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of the treatment. Participants will be monitored for their response to the drug, and the study aims to provide insights into the management of this kidney disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female aged 18-75.
* Understand the nature of the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs within 30 days before the first study administration.
* With previous history of Human immunodeficiency virus(HIV) infection.
* Treponema pallidum antibody positive in screening period.
* May have active Mycobacterium tuberculosis infection.
* Major surgery is planned during the study.
* Other reasons the investigator believes that the subject is not suitable to participate in this study.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jicheng Lv — Peking University First Hospital
• Study coordinator: Qian Jia
• Email: qianjia@keymedbio.com
• Phone: 028-88610620

Similar studies

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

• JADE101 in IgA Nephropathy: a Phase 2 test in adults

  This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.

  Recruiting at 22 sites Phase 2 Jade Biosciences, Inc. · Chula Vista, California and 21 other locations · NCT07541287

• Atrasentan for pediatric primary IgA nephropathy

  This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.

  Recruiting at 19 sites Phase 3 Novartis · Neptune City, New Jersey and 22 other locations · NCT07498335

• Anti-CD19/BCMA universal CAR-T (RD06-05) for autoimmune diseases

  This early-phase test gives a universal CAR-T therapy (RD06-05) that targets CD19 and BCMA to adults with autoimmune diseases such as SLE/lupus nephritis, ANCA-associated vasculitis, and anti-GBM disease.

  Recruiting Early Phase 1 Nanjing Bioheng Biotech Co., Ltd. · Shanghai, Shanghai Municipality · NCT07203404

• BHV-1400 for IgA nephropathy

  This study will try BHV-1400 in adults with biopsy-confirmed IgA nephropathy to see if the drug is safe and tolerable.

  Recruiting at 15 sites Phase 1 Biohaven Pharmaceuticals, Inc. · Farmington, Connecticut and 14 other locations · NCT07054684

• Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria

  This test will see if combining Nefecon (a gut‑targeted budesonide) with ambrisentan can reduce urine protein and slow kidney decline in adults with IgA nephropathy who have at least 0.5 g of protein in a 24‑hour urine collection.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07030894

• Epithelial Dysmetabolism and Kidney Fibrosis in ANCA Vasculitis

  This study tests whether alterations in tubulo-interstitial metabolism relate to how quickly kidney function deteriorates in people with ANCA-associated vasculitis compared to other nephropathies.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07010250

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.