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

RemeGen

Status and phase: Terminated; Phase 2

Conditions: IgA Nephropathy

Treatments: Drug: Placebo; Drug: Telitacicept 160mg; Drug: Telitacicept 240mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04905212

RC18G004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

Telitacicept 160mg

Experimental group

Description:

Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses

Treatment:

Drug: Telitacicept 160mg

Telitacicept 240mg

Experimental group

Description:

Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses

Treatment:

Drug: Telitacicept 240mg

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous injection once weekly, and a total of 24 doses

Treatment:

Drug: Placebo