Assessment of endogenous oxalate production and investigation of glyoxylate/oxalate pathways in primary hyperoxaluria patients and healthy subjects

Completed

• Conditions: Primary hyperoxaluria type 1 and 2; 10027424; 10021605; 10046708

• Registration Number: NL-OMON46913
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

PH patient:
- A diagnosis of Primary Hyperoxaluria type 1 (PH1) or Primary Hyperoxaluria type 2 (PH2) as assessed by DNA mutational analysis
- Age 18 * 65 years;Healthy volunteer:
- Age 18 * 65 years
- eGFR > 80 ml/min · 1.73 m2 (Cockroft-Gault)

Exclusion Criteria

- Acute or chronic disease (other than PH), that would interfere with the subject's safety and ability to comply with protocol requirements.
- Pregnancy or lactation at the time of screening or enrollment
- Any disorder or alteration in mental status that would preclude understanding of the informed consent process and/or completion of the study related evaluations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of appearance (Ra); oxalate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Rate of appearance (Ra): glycolate and glycine.<br /><br>[1-13C] and [U-13C ] enrichment of glycine and oxalate.</p><br>