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.