Status:
TERMINATED
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC...
Detailed Description
IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety...
Eligibility Criteria
Inclusion
- IgA nephropathy confirmed by pathological biopsy;
- Male or female aged ≥ 18 years old;
- Average 24-hour urine total protein ≥ 0.75 g/24 h
- Estimated GFR (using the CKD-EPI formula) \> 30 mL/min per 1.73 m\^2;
- Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.
Exclusion
- Patients with clinically significant abnormal laboratory tests at screening;
- Evidence of rapid eGFR decrease \> 15 ml/min during screening;
- Renal or other organ transplantation prior to, or expected during, the study;
- Patients with secondary IgA nephropathy;
- Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
- Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
- Immunocompromised individuals.
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04905212
Start Date
November 4 2021
End Date
November 9 2023
Last Update
December 6 2023
Active Locations (8)
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1
Remegen Site #5
Los Angeles, California, United States, 90022
2
Remegen Site #13
Los Angeles, California, United States, 91324
3
Remegen Site #14
Los Angeles, California, United States, 91324
4
Remegen Site #10
Sacramento, California, United States, 95687