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Currently Enrolling
Interventional

APPLAUSE-IgAN

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

Brief Description

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023/iptacopan at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Trial Physician / Study Coordinator

Hoa Bui

Email Phone 714-462-2000
Site Name

National Institute of Clinical Research
9191 Westminster Blvd. Suite 208 Garden Grove, CA 92844

Sponsor

Novartis Pharmaceuticals

Study Drug

LNP023/iptacopan

Estimated enrollment

450 patients globally

Estimated end date

January 2025

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

APPLAUSE-IgAN

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

Brief Description

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023/iptacopan at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Trial is for people with

Primary IgA Nephropathy

Study Goal

The purpose of the study is to evaluate the efficacy and safety of LNP023/iptacopan compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients.

What is involved for the Patient?

Patients will be asked to attend a screening visit to assess eligibly. Medical history will be collected. The study team will collect biosamples (blood, urine, biopsy tissue). Visits may be in conjunction with normally scheduled appointments, but additional study visits may be required. If eligible, a patient will receive study medication or placebo on top of standard of care for approximately 2 years and be routinely assessed for safety and efficacy.

About the drug or intervention

LNP023/iptacopan is an investigational drug that we are studying as a potential targeted treatment for people with IgAN and other autoimmune diseases. The term "investigational" means that it is not currently approved for use by the general public. LNP023/iptacopan is thought to block a process in the body known to cause inflammation and kidney damage in people with IgAN and other autoimmune diseases. The APPLAUSE-IgAN trial will study the effects of LNP023/iptacopan on reducing inflammation and kidney damage in people with IgAN.

Find other locations for this trial:
Garden Grove, CA
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
Did you know that some forms of kidney disease can be genetic?Researchers are continually discovering genetic causes of Nephrotic Syndrome.

Learn more about genetic causes of kidney disease and find out if you may be affected.

Learn more

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