RG002C0106 injection for primary IgA nephropathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic/Pharmacodynamic Characteristics of RG002C0106 Injection in Subjects With Primary IgA Nephropathy

This trial will test whether subcutaneous RG002C0106 can reduce urine protein and help preserve kidney function in adults with primary IgA nephropathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07305974 on ClinicalTrials.gov

What this trial studies

This Phase IIa, randomized, double-blind, placebo-controlled multicenter trial gives adults with primary IgA nephropathy subcutaneous RG002C0106 or placebo and follows them for changes in proteinuria and kidney function. The primary objective is change in 24-hour urinary protein excretion and preservation of eGFR, while secondary objectives include characterization of safety, pharmacokinetics, and pharmacodynamics. Key eligibility includes biopsy-proven primary IgA nephropathy within 10 years, 24-hour urine protein ≥0.75 g, eGFR ≥30 mL/min/1.73 m², and required meningococcal and pneumococcal vaccination. Participants will receive scheduled injections and regular clinic visits and laboratory monitoring at participating centers (lead site: Peking University First Hospital).

Who should consider this trial

Good fit: Adults aged 18–65 with biopsy-proven primary IgA nephropathy, 24-hour urine protein ≥0.75 g, eGFR ≥30 mL/min/1.73 m², proof of required vaccinations, and willingness to use contraception are the ideal candidates.

Not a fit: Patients with advanced kidney failure (eGFR <30), unconfirmed or secondary causes of IgA deposition, very low proteinuria, inability to be vaccinated, or inability to attend study visits are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, RG002C0106 could lower proteinuria and slow the decline of kidney function in people with IgA nephropathy.

How similar studies have performed: Other immune-targeting biologic agents in IgA nephropathy have produced reductions in proteinuria in some trials but have not yet demonstrated clear, durable improvements in long-term kidney outcomes.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily participate in the clinical trial and sign the informed consent form (ICF);
2. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the ICF;
3. Body weight ≥ 40 kg;
4. Negative blood pregnancy test result at screening for female participants of childbearing potential;
5. Renal biopsy pathology results within 10 years prior to screening confirming a diagnosis of primary IgA nephropathy;
6. 24-hour urinary protein ≥ 0.75 g/24 h during the screening period;
7. Estimated glomerular filtration rate (eGFR) (calculated using the creatinine-based CKD-EPI formula) ≥ 30 mL/min/1.73 m² during the screening period;
8. Must have received vaccination against Neisseria meningitidis (serogroups A, C, W, Y) and Streptococcus pneumoniae infections at least 2 weeks prior to the first dose of the investigational product and provide proof of such vaccination;
9. Participants must agree and require their partners to use adequate contraception from the time of signing the ICF, throughout the study, and for at least 3 months after the study ends . Male participants must not donate sperm for at least 6 months after the last dose of the investigational product.

Exclusion Criteria:

1. Patients with secondary IgA nephropathy ;
2. Renal biopsy pathology shows renal tubular atrophy or interstitial fibrosis ≥ 50%; or crescent formation in ≥ 50% of glomeruli ;
3. Acute kidney injury or rapidly progressive glomerulonephritis within 4 weeks prior to screening ;
4. 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;
5. Any of the following abnormal laboratory results at screening:

   * Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN);
   * Total bilirubin (TB) \> 1.5 × ULN. However, for patients with a confirmed diagnosis of Gilbert's syndrome, if TB \> 1.5 × ULN but conjugated bilirubin \< ULN, they may be enrolled;
6. Positive test results at screening for HBsAg, HCV Ab,HIV-IgG, or TP-Ab;
7. Poorly controlled type 1 or type 2 diabetes during the screening period ;
8. Persistent clinically significant elevated blood pressure during the screening period ;
9. Patients with immunodeficiency diseases;
10. Patients with splenic insufficiency (e.g., asplenia or history of splenectomy);
11. History of kidney transplantation or organ transplantation (including bone marrow transplantation, stem cell transplantation, etc.);
12. Suspected or confirmed history of hereditary complement deficiency;
13. History of any tumor within 5 years before screening, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and squamous cell carcinoma of the skin that have been completely cured after treatment;
14. History of meningococcal infection within 12 months before screening;
15. Active or suspected viral, bacterial, fungal, or parasitic infection within 14 days prior to investigational product administration;
16. History of allergic reactions to oligonucleotides or N-acetylgalactosamine (GalNAc);
17. History of intolerance to subcutaneous injections or significant abdominal scarring that may impede administration or local tolerance assessment of the investigational product;
18. Treatment with small-molecule complement inhibitors (e.g., iptacopan) within 3 months prior to investigational product administration, or previous treatment failure or intolerance;
19. History of clinically significant severe infection within 3 months prior to screening, as determined by the investigator;
20. Major surgery or severe trauma within 3 months prior to investigational product administration, incomplete recovery, or planned surgery during the study;
21. Participation in any investigational drug or medical device clinical trial within 1 month prior to investigational product administration (excluding screen failures);
22. Any other condition considered by the investigator to make the participant unsuitable for inclusion.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hongwei Tian

Conditions IgA Nephropathy; IgAN