Actively Recruiting
A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
Led by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 65 years at consent
- Body weight at least 40 kg
- Negative pregnancy test for women of childbearing potential at screening
- Kidney biopsy confirming primary IgA nephropathy within 10 years before screening
- 24-hour urinary protein of 0.75 g or more at screening
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher at screening
- Vaccinated against Neisseria meningitidis (A, C, W, Y) and Streptococcus pneumoniae at least 2 weeks before first dose
- Agree to use adequate contraception during the study and for 3 months after; male participants must not donate sperm for 6 months after last dose
You will not qualify if you...
- Secondary IgA nephropathy diagnosis
- Kidney biopsy showing 50% or more tubular atrophy, interstitial fibrosis, or crescent formation
- Acute kidney injury or rapidly progressing glomerulonephritis within 4 weeks before screening
- Nephrotic syndrome with urine protein over 3.5 g/24h, low serum albumin, high cholesterol, and edema
- Elevated liver enzymes or bilirubin above set limits except for Gilbert's syndrome cases
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis at screening
- Poorly controlled type 1 or type 2 diabetes
- Persistently high blood pressure during screening
- Immunodeficiency diseases
- History of spleen removal or spleen function problems
- History of any organ transplantation
- Suspected or confirmed hereditary complement deficiency
- Cancer history within 5 years except certain cured skin or cervical cancers
- Meningococcal infection within 12 months before screening
- Active or suspected infection within 14 days before treatment
- Allergy to oligonucleotides or N-acetylgalactosamine
- Intolerance to subcutaneous injections or significant abdominal scarring
- Treatment with small-molecule complement inhibitors within 3 months before study
- Severe infection within 3 months before screening
- Major surgery or trauma within 3 months before treatment or planned surgery during study
- Participation in another clinical trial within 1 month before treatment
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
H
Hongwei Tian
CONTACT
L
Lingling Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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