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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Telitacicept 160mg Drug: Telitacicept 240mg Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Actual Study Start Date : November 4, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Telitacicept 160mg
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Drug: Telitacicept 160mg
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.

Experimental: Telitacicept 240mg
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Drug: Telitacicept 240mg
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.

Placebo Comparator: Placebo
Placebo subcutaneous injection once weekly, and a total of 24 doses
Drug: Placebo
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)


Other Outcome Measures:
  1. The incidence and severity of adverse events [ Time Frame: 27 weeks ]
    Number and intensity of adverse events

  2. Immunogenicity endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24 and 27 ]
    Anti-drug antibody (ADA), incidence, titers and duration

  3. 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

  4. Pharmacokinetic endpoints [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24 and 27 ]
    Free Telitacicept serum concentration and total Telitacicept serum concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905212


Contacts
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Contact: Remegen Biosciences 1-301-284-1015 RC18_IGANstudy@remegenbio.com

Locations
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United States, California
Remegen Site #5 Recruiting
Los Angeles, California, United States, 90022
Remegen Site #4 Recruiting
Los Angeles, California, United States, 90033
Remegen Site #13 Recruiting
Los Angeles, California, United States, 91324
Remegen Site #14 Recruiting
Los Angeles, California, United States, 91324
Remegen Site #6 Recruiting
Los Angeles, California, United States, 92868
Remegen Site #10 Recruiting
Sacramento, California, United States, 95687
Remegen Site #8 Recruiting
San Francisco, California, United States, 94080
United States, Florida
Remegen Site #16 Recruiting
Fort Lauderdale, Florida, United States, 33071
Remegen Site #12 Recruiting
Orlando, Florida, United States, 32792
Remegen Site #15 Recruiting
West Palm Beach, Florida, United States, 33462
United States, Georgia
Remegen Site #17 Recruiting
Augusta, Georgia, United States, 30909
United States, Pennsylvania
Remegen Site #2 Recruiting
Philadelphia, Pennsylvania, United States, 17033
United States, Texas
Remegen Site #7 Recruiting
Dallas, Texas, United States, 75231
Remegen Site #3 Recruiting
El Paso, Texas, United States, 79925
United States, Utah
Remegen Site #11 Withdrawn
Salt Lake City, Utah, United States, 84088
United States, Virginia
Remegen Site #1 Recruiting
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
RemeGen Co., Ltd.
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Responsible Party: RemeGen Co., Ltd.
ClinicalTrials.gov Identifier: NCT04905212    
Other Study ID Numbers: RC18G004
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RemeGen Co., Ltd.:
Berger Disease
Berger's Disease
IGA Glomerulonephritis
IGA Nephropathy
Primary IGA Nephropathy
Immunoglobulin A Nephropathy Nephritis
IGA Type Nephropathy, IGA
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases