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New treatment option for IgA Nephropathy (IgAN)
Official title A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT07305974
What this study is testing
What is RG002C0106?
RG002C0106 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for iga nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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;
You likely can't join 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 \ 350 mg/dL), and edema;
- Any of the following abnormal laboratory results at screening:
- Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN);
See the full eligibility criteria
- 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;
- 24-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...
- 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...
- 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 \ 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...
- History of meningococcal infection within 12 months before screening;
- Active or suspected viral, bacterial, fungal, or parasitic infection within 14 days prior to investigational product administration;
- History of allergic reactions to oligonucleotides or N-acetylgalactosamine (GalNAc);
- History of intolerance to subcutaneous injections or significant abdominal scarring that may impede administration or local tolerance assessment of the investigational product;
- Treatment with small-molecule complement inhibitors (e.g., iptacopan) within 3 months prior to investigational product administration, or previous treatment failure or intolerance;
- History of clinically significant severe infection within 3 months prior to screening, as determined by the investigator;
- Major surgery or severe trauma within 3 months prior to investigational product administration, incomplete recovery, or planned surgery during the study;
- Participation in any investigational drug or medical device clinical trial within 1 month prior to investigational product administration (excluding screen failures);
- Any other condition considered by the investigator to make the participant unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.