Observational Study
researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease.
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 Physician / Study Coordinator
Laurie Jones
EmailSite Name
Dallas Renal Group
7777 Forest Ln Ste C-865 Dallas, TX 75230
Sponsor
Calliditas Therapeutics
Study Drug
TARPEYO®
Estimated enrollment
60
Estimated end date
04/2027
Observational Study
researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease.
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.