IgA Nephropathy
Conditions
Keywords
Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA
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).
Interventions
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
DRUGPlacebo
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 24-hour urine protein at Week 24. | Week 24 | Change from baseline in urine protein over 24 hours to Week 24 will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48 | 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; | 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. | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of adverse events | 27 weeks | Number and intensity of adverse events |
| Immunogenicity endpoints | Week 0, 4, 8, 12, 16, 20, 24 and 27 | Anti-drug antibody (ADA), incidence, titers and duration |
| Biomaker endpoints serum concentration | Week 0, 4, 8, 12, 16, 20, and 24 | BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex |
| Pharmacokinetic endpoints | Week 0, 4, 8, 12, 16, 20, 24 and 27 | Free Telitacicept serum concentration and total Telitacicept serum concentration |
Countries
United States
Outcome results
None listed