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

IgA Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04905212
• Other study ID #: RC18G004
• Status: Terminated
• Phase: Phase 2
• Start date: November 4, 2021
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: RemeGen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Remegen Site #17	Augusta	Georgia
United States	Remegen Site #16	Fort Lauderdale	Florida
United States	Remegen Site #13	Los Angeles	California
United States	Remegen Site #14	Los Angeles	California
United States	Remegen Site #5	Los Angeles	California
United States	Remegen Site #2	Philadelphia	Pennsylvania
United States	Remegen Site #10	Sacramento	California
United States	Remegen Site #8	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence and severity of adverse events	Number and intensity of adverse events	27 weeks
Other	Immunogenicity endpoints	Anti-drug antibody (ADA), incidence, titers and duration	Week 0, 4, 8, 12, 16, 20, 24 and 27
Other	Biomaker endpoints serum concentration	BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex	Week 0, 4, 8, 12, 16, 20, and 24
Other	Pharmacokinetic endpoints	Free Telitacicept serum concentration and total Telitacicept serum concentration	Week 0, 4, 8, 12, 16, 20, 24 and 27
Primary	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	Week 24
Secondary	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	Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Secondary	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.	Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Secondary	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)	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.