A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

Part of paid clinical trials in Los Angeles, California.

Sponsor
RemeGen Co., Ltd.
Study ID
NCT04905212
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept 160mg — DRUG
    Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
  • Telitacicept 240mg — DRUG
    Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
  • Placebo — DRUG
    Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.

Study Details

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 (RC18) in the treatment of IgA nephropathy.

Key Dates

Start date
Nov 4, 2021
Status verified
Nov 2023
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept 160mg
    Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
  • Experimental: Telitacicept 240mg
    Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
  • Placebo Comparator: Placebo
    Placebo subcutaneous injection once weekly, and a total of 24 doses

Primary Outcome Measure

Change from baseline in 24-hour urine protein at Week 24. [ Time Frame: Week 24 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Remegen Site #13Los AngelesCalifornia91324-
Remegen Site #14Los AngelesCalifornia91324-
Remegen Site #5Los AngelesCalifornia90022-
Remegen Site #10SacramentoCalifornia95687-
Remegen Site #8San FranciscoCalifornia94080-
Remegen Site #16Fort LauderdaleFlorida33071-
Remegen Site #17AugustaGeorgia30909-
Remegen Site #2PhiladelphiaPennsylvania17033-

Find similar trials in Los Angeles, CA

By research site
Remegen· Los Angeles, CARemegen· Sacramento, CARemegen· San Francisco, CARemegen· Fort Lauderdale, FLRemegen· Augusta, GARemegen· Philadelphia, PA

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