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

NCT07305974 | Recruiting Phase 2

• 1 other identifier: RG002C0106-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

IgA Nephropathy (IgAN)

Keywords

IgAN

Outcome Measures

Primary Outcomes (2)

• The percentage change from baseline in the mean 24hUPCR)at Week 24 after the first subcutaneous admini;

  up to 169 days

• Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.

  up to 169 days

Study Arms (2)

Experimental: RG002C0106

EXPERIMENTAL

Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration

Drug: RG002C0106

Placebo Comparator: placebo

PLACEBO COMPARATOR

Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration

Drug: placebo subcutaneous administration

Interventions

RG002C0106 DRUG

RG002C0106 for subcutaneous (SC) injection

Experimental: RG002C0106

placebo subcutaneous administration DRUG

The placebo is made of normal saline.

Placebo Comparator: placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Renal biopsy pathology results within 10 years prior to screening confirming a diagnosis of primary IgA nephropathy;
• hour urinary protein ≥ 0.75 g/24 h during the screening period;
• Estimated glomerular filtration rate (eGFR) (calculated using the creatinine-based CKD-EPI formula) ≥ 30 mL/min/1.73 m² during the screening period;
• 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;
• 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.

You may not qualify if:

• 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;
• 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;
• Positive test results at screening for HBsAg, HCV Ab,HIV-IgG, or TP-Ab;
• Poorly controlled type 1 or type 2 diabetes during the screening period ;
• Persistent clinically significant elevated blood pressure during the screening period ;
• Patients with immunodeficiency diseases;
• Patients with splenic insufficiency (e.g., asplenia or history of splenectomy);
• History of kidney transplantation or organ transplantation (including bone marrow transplantation, stem cell transplantation, etc.);
• Suspected or confirmed history of hereditary complement deficiency;
• 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;

Sponsors & Collaborators

• Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hongwei Tian

CONTACT

861063729218; hwtian@rigerna.com

Lingling Zhu

CONTACT

861063729218; llzhu@rigerna.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 26, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)