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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46913

Enrollment

Registered

2017-06-29

Start date

2017-09-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hyperoxaluria type 1 and 2

Interventions

(continuous primed) infusion with stable isotopes (identical for both groups): [U-13C]sodium-oxalate, [1-13C] Glycolate and [D5] Glycine

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Rate of appearance (Ra); oxalate.	—

Secondary

Measure	Time frame
Rate of appearance (Ra): glycolate and glycine. [1-13C] and [U-13C ] enrichment of glycine and oxalate.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)