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Trial record 1 of 1 for:    NCT04905212
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A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT04905212
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
RemeGen Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 21, 2021
First Posted Date  ICMJE May 27, 2021
Last Update Posted Date February 24, 2022
Actual Study Start Date  ICMJE November 4, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2021)
Change from baseline in 24-hour urine protein at Week 24. [ Time Frame: Week 24 ]
Change from baseline in urine protein over 24 hours to Week 24 will be measured
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
  • Change from baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Change from baseline in eGFR by visit
  • Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) [ Time Frame: Week 0, 4, 8, 12, 16, 20 and 24 ]
    Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
  • Changes from baseline in immunological parameters [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24 and 27 ]
    Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2021)
  • Change from baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Change from baseline in eGFR by visit
  • Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
  • Changes from baseline in immunological parameters [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)
Current Other Pre-specified Outcome Measures
 (submitted: February 7, 2022)
  • The incidence and severity of adverse events [ Time Frame: 27 weeks ]
    Number and intensity of adverse events
  • Immunogenicity endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24 and 27 ]
    Anti-drug antibody (ADA), incidence, titers and duration
  • Biomaker endpoints serum concentration [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex
  • Pharmacokinetic endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24 and 27 ]
    Free Telitacicept serum concentration and total Telitacicept serum concentration
Original Other Pre-specified Outcome Measures
 (submitted: May 23, 2021)
  • The incidence and severity of adverse events [ Time Frame: 24 weeks ]
    Number and intensity of adverse events
  • Immunogenicity endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Anti-drug antibody (ADA), incidence, titers and duration
  • Biomaker endpoints serum concentration [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex
  • Pharmacokinetic endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, and 24 ]
    Free Telitacicept serum concentration and total Telitacicept serum concentration
 
Descriptive Information
Brief Title  ICMJE A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Brief Summary This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
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 and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

The study is composed of 3 parts: a screening period, a double-blind treatment period, and a follow-up period. Subjects with confirmed IgA nephropathy within 8 years will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE
  • Drug: Telitacicept 160mg
    Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
  • Drug: Telitacicept 240mg
    Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
  • Drug: Placebo
    Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Study Arms  ICMJE
  • Experimental: Telitacicept 160mg
    Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
    Intervention: Drug: Telitacicept 160mg
  • Experimental: Telitacicept 240mg
    Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
    Intervention: Drug: Telitacicept 240mg
  • Placebo Comparator: Placebo
    Placebo subcutaneous injection once weekly, and a total of 24 doses
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. IgA nephropathy confirmed by pathological biopsy within 8 years prior to randomization;
  2. Male or female aged ≥ 18 years old and ≤ 70 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:

  1. Patients with clinically significant abnormal laboratory tests at screening;
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Remegen Biosciences 1-301-284-1015 RC18_IGANstudy@remegenbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04905212
Other Study ID Numbers  ICMJE RC18G004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party RemeGen Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RemeGen Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RemeGen Co., Ltd.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP