RESOURCES

/

FIND A SPECIALIST

/

CONTACT

Not yet recruiting
Observational

NefXtend

Efficacy and safety of extended TARPEYO® (budesonide) delayed release capsules treatment beyond 9 months in adult patients

Brief Description

The study assesses the efficacy and safety of extended TARPEYO® treatment in adult participants who have completed 9 months of TARPEYO 16 mg daily treatment. The study treatment period is 15 months; TARPEYO 16 mg daily dose will be taken for 6-months followed by 8 mg daily dose for 9-months.

Not yet recruiting
Observational

NefXtend

Efficacy and safety of extended TARPEYO® (budesonide) delayed release capsules treatment beyond 9 months in adult patients

Brief Description

The study assesses the efficacy and safety of extended TARPEYO® treatment in adult participants who have completed 9 months of TARPEYO 16 mg daily treatment. The study treatment period is 15 months; TARPEYO 16 mg daily dose will be taken for 6-months followed by 8 mg daily dose for 9-months.

Trial is for people with

Patients on current TARPEYO treatment

Study Goal

NefXtend seeks to assess the treatment benefit on kidney function (UPCR, eGFR, 24-hour proteinuria, and microhematuria) as well as evaluate the safety of a 15-month treatment extension of TARPEYO in patients with further treatment needs.

What is involved for the Patient?

Patients consenting to study participation will complete screening assessments prior to stopping their current TARPEYO treatment. Patients qualifying for the study will have 7 study visits over 18 months. Participants’ health is monitored by blood and urine testing, blood pressure and heart rate measurements, and physical exams.

About the drug or intervention

TARPEYO® is recommended as a 9-month treatment. The extended use of TARPEYO in this clinical study is investigational.

Dallas, TX (Dallas Renal Group)
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.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.