Actively Recruiting
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of RG002C0106 Injection in 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of RG002C0106 in people with primary IgA nephropathy, a specific kidney disease. This Phase IIa study is conducted at multiple centers and uses a double-blind design, in which neither patients nor doctors know who receives the treatment or placebo. The main goal is to see if RG002C0106 can reduce protein in the urine and protect kidney function, along with assessing safety and how the drug behaves in the body. Participants are randomly assigned to receive either the investigational drug RG002C0106 or a placebo, both given by subcutaneous injection. The study lasts up to 169 days, during which patients receive treatment and are monitored closely. The placebo consists of normal saline injections. This design helps compare the effects of RG002C0106 against no active drug while maintaining blinding. During the study, participants undergo various evaluations including urine protein tests over 24 hours and kidney function measurements. Researchers also track any side effects or serious adverse events related to the treatment. Vaccination status and contraception use are monitored to ensure participant safety. The study collects data over about 24 weeks after the first injection to understand how the drug impacts kidney disease and its safety profile.
CONDITIONS
Brief 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 of at least 40 kg
- Negative blood pregnancy test for women of childbearing potential
- Diagnosis of primary IgA nephropathy confirmed by kidney biopsy within 10 years
- Urinary protein of at least 0.75 g per 24 hours during screening
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² at screening
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks before first dose
- Willingness to use adequate contraception during the study and for 3 months after, with male partners not donating sperm for 6 months after last dose
You will not qualify if you...
- Secondary IgA nephropathy diagnosis
- Kidney biopsy showing severe tubular atrophy, interstitial fibrosis, or crescent formation (50% or more)
- Acute kidney injury or rapidly worsening kidney inflammation within 4 weeks before screening
- Nephrotic syndrome with high proteinuria, low albumin, high cholesterol, and swelling
- Abnormal liver tests beyond specified limits or positive viral infection tests
- Poorly controlled diabetes
- Persistent high blood pressure during screening
- Immunodeficiency or splenic insufficiency
- History of any organ transplant
- Suspected hereditary complement deficiency
- Recent tumor history except certain skin and cervical cancers fully treated
- Recent meningococcal infection
- Active or suspected infection within 14 days before treatment
- Allergic reaction history to oligonucleotides or GalNAc
- Intolerance to subcutaneous injections or significant abdominal scarring
- Recent use or intolerance of complement inhibitors
- Recent severe infection, major surgery, or trauma
- Participation in other investigational drug or device trials within 1 month
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants receive subcutaneous injections of RG002C0106 or placebo to evaluate safety and efficacy in primary IgA nephropathy.
Regular visits for injections and assessments during treatment period
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
H
Hongwei Tian
L
Lingling Zhu
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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