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

University of Kansas

Status and phase: Withdrawn; Phase 2

Conditions: Kidney Stones

Treatments: Drug: Pyridoxamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00490113

10417 (Other Identifier)

1R21DK072454-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pyridoxamine