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
Verified date | November 2023 |
Source | RemeGen Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
RemeGen Co., Ltd. |
United States,
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. |
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