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

Phase 2

Withdrawn

• Conditions: Kidney Stones
• Interventions: Drug: Pyridoxamine

• Registration Number: NCT00490113
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Pyridoxamine	-

Primary Outcome Measures

Name	Time	Method
Urinary Excretion of Oxalate at Highest Dose	4 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Urinary Supersaturation	4 Weeks