Overview

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

Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
RemeGen Co., Ltd.
Criteria
Inclusion Criteria:

1. IgA nephropathy confirmed by pathological biopsy within 8 years prior to
randomization;

2. Male or female aged ≥ 18 years old and ≤ 70 years old;

3. Average 24-hour urine total protein ≥ 1 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.