nefXtend study: Extension for TARPEYO® (budesonide) delayed release capsules

About

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.

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

Qualifications

You may qualify for the NefXtend Study if you:

• Are an adult with IgA nephropathy (IgAN)

• Are currently on TARPEYO®

• Have proteinuria of at least 0.5 g/day or a UPCR of at least 0.3 g/gram

• Have not had a kidney transplant

• Are not on dialysis

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 required 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 at our office in Austell, GA. Participants’ health is monitored by blood and urine testing, blood pressure and heart rate measurements, and physical exams.

Compensation

A stipend and travel expense reimbursement will be provided for participants of the study. Please complete the patient interest form to connect with our practice for further details.

Join us in advancing treatments for IgAN and improving outcomes for patients worldwide. Follow the link below to express your interest in participating!