A Phase 2 interventional study of RC18 160mg and RC18 240mg in Primary IgA Nephropathy, sponsored by RemeGen Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by RemeGen Co., Ltd. · Phase 2, Interventional, and Treatment
To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.
Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai.
After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →RemeGen Co., Ltd. is the lead sponsor of 77 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RC18 160mg subcutaneous injection (S.C.) once weekly ,and a total of 24 doses
Biological: RC18 160mg
RC18 240mg S.C. once weekly ,and a total of 24 doses
Biological: RC18 240mg
Placebo S.C. once weekly ,and a total of 24 doses
Biological: placebo
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
Also known as: Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
Also known as: Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
Change from baseline in 24-hour urine protein excretion at Week 24;
based on the 24 -hour urine collection
Time frame: week 24
Change from baseline in estimated Glomerular Filtration Rate(eGFR)
eGFR is calculated using the CKD-EPI method.
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in urine protein/creatine ratio(UPCR) and/or urine albumin/ creatine ratio(UACR)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin G(IgG);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin M(IgM);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin A(IgA);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in the count of urine red blood cells
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in the count of B-lymphocytes (CD19+)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in complement 3(C3)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in complement 4 (C4)
Time frame: week 0, 4, 8, 12, 16, 20, 24
The incidence rate and severity of adverse events.
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Time frame: week 0, 4, 8, 12, 16, 20, 24
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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RemeGen Co., Ltd.