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Interventional

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

A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

Brief Description

IgA nephropathy, also known as Berger’s Disease, is a kidney disease in which IgA, a protein meant to help the body fight infections, accumulates in the kidneys and damages them. This study is seeking to determine the safety and effectiveness of Telitacicept in the treatment of IgA nephropathy. A clinical study using this investigational new drug in China showed potential benefit in treating IgAN by reducing urine protein. However, more clinical data is needed to further evaluate the effectiveness and safety of Telitacicept in IgAN patients.

Trial Physician / Study Coordinator

Tyrone Rosales

Email Phone 818-470-9212
Address

Sponsor

RemeGen Co., Ltd.

Study Drug

Telitacicept (RC18)

Estimated enrollment

30

Estimated end date

June 2022

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Find other locations for this trial:
Currently Enrolling
Interventional

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

A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

Brief Description

IgA nephropathy, also known as Berger’s Disease, is a kidney disease in which IgA, a protein meant to help the body fight infections, accumulates in the kidneys and damages them. This study is seeking to determine the safety and effectiveness of Telitacicept in the treatment of IgA nephropathy. A clinical study using this investigational new drug in China showed potential benefit in treating IgAN by reducing urine protein. However, more clinical data is needed to further evaluate the effectiveness and safety of Telitacicept in IgAN patients.

Trial is for people with

IgA Nephropathy

Study Goal

To determine the safety and effectiveness of Telitacicept in the treatment of IgA nephropathy The primary outcome measure is the change from baseline in 24-hour urine protein at Week 24.

What is involved for the Patient?

The study is composed of 3 parts: a screening period, a double-blind treatment period, and a safety follow-up period. Subjects with confirmed IgA nephropathy within 8 years will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm). There is a 2 in 3 chance of receiving Telitacicept and a 1 in 3 chance of receiving placebo.

About the drug or intervention

Telitacicept (RC18) targets two cell-signaling molecules critical for B-lymphocyte development. This allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases including IgA Nephropathy.

Find other locations for this trial:
Northridge, CA (Second 91324)
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions