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

Primary Purpose

IgA Nephropathy

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telitacicept 160mg
Telitacicept 240mg
Placebo
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. IgA nephropathy confirmed by pathological biopsy;
  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:

  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.

Sites / Locations

  • Remegen Site #5
  • Remegen Site #13
  • Remegen Site #14
  • Remegen Site #10
  • Remegen Site #8
  • Remegen Site #16
  • Remegen Site #17
  • Remegen Site #2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Telitacicept 160mg

Telitacicept 240mg

Placebo

Arm Description

Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses

Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses

Placebo subcutaneous injection once weekly, and a total of 24 doses

Outcomes

Primary Outcome Measures

Change from baseline in 24-hour urine protein at Week 24.
Change from baseline in urine protein over 24 hours to Week 24 will be measured

Secondary Outcome Measures

Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in eGFR by visit
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)

Full Information

First Posted
May 21, 2021
Last Updated
August 28, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04905212
Brief Title
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Official Title
A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept 160mg
Arm Type
Experimental
Arm Description
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Arm Title
Telitacicept 240mg
Arm Type
Experimental
Arm Description
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous injection once weekly, and a total of 24 doses
Intervention Type
Drug
Intervention Name(s)
Telitacicept 160mg
Intervention Description
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Intervention Type
Drug
Intervention Name(s)
Telitacicept 240mg
Intervention Description
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Primary Outcome Measure Information:
Title
Change from baseline in 24-hour urine protein at Week 24.
Description
Change from baseline in urine protein over 24 hours to Week 24 will be measured
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Description
Change from baseline in eGFR by visit
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Title
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Description
Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Title
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Description
Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Other Pre-specified Outcome Measures:
Title
The incidence and severity of adverse events
Description
Number and intensity of adverse events
Time Frame
27 weeks
Title
Immunogenicity endpoints
Description
Anti-drug antibody (ADA), incidence, titers and duration
Time Frame
Week 0, 4, 8, 12, 16, 20, 24 and 27
Title
Biomaker endpoints serum concentration
Description
BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex
Time Frame
Week 0, 4, 8, 12, 16, 20, and 24
Title
Pharmacokinetic endpoints
Description
Free Telitacicept serum concentration and total Telitacicept serum concentration
Time Frame
Week 0, 4, 8, 12, 16, 20, 24 and 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Remegen Site #5
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Remegen Site #13
City
Los Angeles
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Remegen Site #14
City
Los Angeles
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Remegen Site #10
City
Sacramento
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Remegen Site #8
City
San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Remegen Site #16
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Remegen Site #17
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Remegen Site #2
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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