A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
NCT ID: NCT04905212
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2021-11-04
2023-11-09
Brief Summary
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Detailed Description
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The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telitacicept 160mg
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Telitacicept 160mg
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Telitacicept 240mg
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Telitacicept 240mg
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Placebo
Placebo subcutaneous injection once weekly, and a total of 24 doses
Placebo
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Interventions
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Telitacicept 160mg
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Telitacicept 240mg
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Placebo
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged ≥ 18 years old;
3. Average 24-hour urine total protein ≥ 0.75 g/24 h
4. Estimated GFR (using the CKD-EPI formula) \> 30 mL/min per 1.73 m\^2;
5. Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.
Exclusion Criteria
2. Evidence of rapid eGFR decrease \> 15 ml/min during screening;
3. Renal or other organ transplantation prior to, or expected during, the study;
4. Patients with secondary IgA nephropathy;
5. 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;
6. Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
7. Immunocompromised individuals.
18 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Remegen Site #5
Los Angeles, California, United States
Remegen Site #13
Los Angeles, California, United States
Remegen Site #14
Los Angeles, California, United States
Remegen Site #10
Sacramento, California, United States
Remegen Site #8
San Francisco, California, United States
Remegen Site #16
Fort Lauderdale, Florida, United States
Remegen Site #17
Augusta, Georgia, United States
Remegen Site #2
Philadelphia, Pennsylvania, United States
Countries
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References
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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Other Identifiers
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RC18G004
Identifier Type: -
Identifier Source: org_study_id