A Study Of Patients With Primary Hyperoxaluria Type 3 With A History Of Stone Events

Overview

About this study

The objective of this study is to collect data on stone formation and the degree of nephrocalcinosis in patients (≥ 2 years of age) with genetically confirmed PH3 and relatively intact renal function and to explore the potential relationship between Uox and new stone formation.

This is a natural history study of adults, adolescents, and children (≥ 2 years of age) with genetically confirmed primary hyperoxaluria type 3 (PH3) who have a history of stone events during the last 3 years and/or the presence of pre-existing stones detected by renal ultrasound at Screening.

The relationship between the level of Uox and the incidence of kidney stones and/or nephrocalcinosis in patients with PH3 has not been established. The goal of this study is to record 24-hour Uox levels and the incidence of new stone formation and/or the degree of nephrocalcinosis in patients with PH3 over time.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Genetically confirmed PH3.
  • History of stone events (defined as presence of calcifications in the urinary tract  and/or kidney, their relative location, and the number and size of stones) during the  last 3 years and/or presence of pre existing stones detected by renal ultrasound at  Screening.
  • Uox > 0.7 mmol/24 hours normalized to 1.73 m^2 BSA.
  • eGFR at Screening ≥ 30 mL/min.
  • Able to accommodate 24-hour urine collection.

Exclusion Criteria:  

  • Prior or planned liver transplant within study period.
  • Currently receiving dialysis or anticipating dialysis during study period.
  • Unwillingness to comply with study procedures.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Closed for enrollment

Contact information:

Carly Banks

(800) 270-4637

hyperoxaluriacenter@mayo.edu

More information

Publications

Publications are currently not available