A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria

Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490113

Enrollment

Registered

2007-06-22

Start date

2007-01-31

Completion date

Unknown

Last updated

2017-01-05

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

Conditions

Kidney Stones

Brief summary

To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.

Interventions

DRUGPyridoxamine

Two 250 mg capsules, or placebo, given twice a day for four, 4 week periods. Subjects with primary hyperoxaluria will aslo receive escalated doses up to 3500 mg/day for up to 6 1/2 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults \> 18 years * History of stone formation * Good Renal function * Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study

Exclusion criteria

* Pregnancy * Hyperparathyroidism * Enteric hyperoxaluria. * Obstructive uropathy * Infection (struvite) stones * Severe dietary Ca++ restriction or deficiency * Recent significant cardio-vascular events

Design outcomes

Primary

Measure	Time frame
Urinary Excretion of Oxalate at Highest Dose	4 Weeks

Secondary

Measure	Time frame
Change in Urinary Supersaturation	4 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026