Health TrialsbyHealthPanel

Study of CM313 in Subject With IgA Nephropathy

ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd

About this trial

This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to comprehend the research study and voluntarily signing the informed consent form (ICF).

Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.

Estimated Glomerular Filtration Rate (eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration formula) ≥ 30 mL/min/1.73 (m*m) at screening and baseline.

Prior to the baseline visit, all subjects must have received standard care treatment, including good blood pressure control and a stable treatment of a maximum recommended or maximum tolerated dose of angiotensin-converting enzyme inhibitors(ACEI) or Angiotensin receptor blocker(ARB) for at least 12 weeks.

Disqualifiers

Secondary IgAN judged by the investigator: Secondary IgAN may be associated with Henoch-Schonlein purpura, hepatic cirrhosis, coeliac disease, human immunodeficiency virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, obliterative bronchiolitis, inflammatory bowel disease, familial Mediterranean fever, etc.

Known allergy to monoclonal antibody drugs or to the excipients of CM313.

Presence of rapidly progressive glomerulonephritis (RPGN), defined as 50% decline in eGFR within 3 months prior to randomization and/or crescent formation in more than 50% of glomeruli in a renal pathological specimen.

Confirmed acute kidney injury (AKI) within 4 weeks prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CM313

    Biological/Vaccine

    CM313(SC) injection

  • Placebo

    Drug

    Matched placebo

Treatment groups

106 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A: CM313 low doseExperimental treatment 1 intervention
Group B: Part A: CM313 high doseExperimental treatment 1 intervention
Group C: Part B: CM313 low dose with low frequencyExperimental treatment 1 intervention
Group D: Part B: CM313 low dose with high frequencyExperimental treatment 1 intervention
Group E: Part B: Placebo matching the volume of low dose CM313Placebo comparator 1 intervention
Group F: Part B: CM313 high dose with low frequencyExperimental treatment 1 intervention
Group G: Part B: CM313 high dose with high frequencyExperimental treatment 1 intervention
Group H: Part B: Placebo matching the volume of high dose CM313Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Adverse Events (AEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Time frame
Up to 108 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: