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

University of Kansas Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Kidney Stones

Interventions

PyridoxamineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Urinary Excretion of Oxalate at Highest Dose

Time frame: 4 Weeks

Secondary Outcomes

Change in Urinary Supersaturation

Time frame: 4 Weeks

Data from ClinicalTrials.gov

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