A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.

About this trial

This study looks at how well and safely RG002C0106 works for patients with certain kidney disease: primary IgA nephropathy. It's a phase IIa trial done at several locations where both patients and doctors unknow what treatment is being given.

Eligibility criteria

Qualifiers

Voluntarily participate in the clinical trial and sign the informed consent form (ICF);

Male or female participants aged 18 to 65 years (inclusive) at the time of signing the ICF;

Body weight ≥ 40 kg;

Negative blood pregnancy test result at screening for female participants of childbearing potential;

Disqualifiers

Patients with secondary IgA nephropathy ;

Renal biopsy pathology shows renal tubular atrophy or interstitial fibrosis ≥ 50%; or crescent formation in ≥ 50% of glomeruli ;

Acute kidney injury or rapidly progressive glomerulonephritis within 4 weeks prior to screening ;

Patients with nephrotic syndrome, defined as: 24-hour urinary protein (24h-UP) >3.5 g with hypoalbuminemia (serum albumin <3.0 g/dL), hypercholesterolemia (total cholesterol >350 mg/dL), and edema;

Trial design

Treatments tested in this trial

  • RG002C0106
  • placebo subcutaneous administration

Treatment groups

30 Participants
are divided into 2 treatment groups