Clinical trial NCT04905212: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: IgA Nephropathy
Keywords: Berger Disease
Berger's Disease
IGA Glomerulonephritis
IGA Nephropathy
Primary IGA Nephropathy
Immunoglobulin A Nephropathy Nephritis
IGA Type Nephropathy, IGA
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in 24-hour urine protein at Week 24.
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
measure: 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;
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
measure: 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.
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Other outcomes:
measure: The incidence and severity of adverse events
timeFrame: 27 weeks
measure: Immunogenicity endpoints
timeFrame: Week 0, 4, 8, 12, 16, 20, 24 and 27
measure: Biomaker endpoints serum concentration
timeFrame: Week 0, 4, 8, 12, 16, 20, and 24
measure: Pharmacokinetic endpoints
timeFrame: Week 0, 4, 8, 12, 16, 20, 24 and 27
Locations:
city: Los Angeles
country: United States
facility: Remegen Site #5
state: California
city: Los Angeles
country: United States
facility: Remegen Site #13
state: California
city: Los Angeles
country: United States
facility: Remegen Site #14
state: California
city: Sacramento
country: United States
facility: Remegen Site #10
state: California
city: San Francisco
country: United States
facility: Remegen Site #8
state: California
city: Fort Lauderdale
country: United States
facility: Remegen Site #16
state: Florida
city: Augusta
country: United States
facility: Remegen Site #17
state: Georgia
city: Philadelphia
country: United States
facility: Remegen Site #2
state: Pennsylvania
Study officials:
References: