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

Kidney Stones Clinical Trial

Official title:

Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00490113
• Other study ID #: 10417
• Secondary ID: 1R21DK072454-02
• Status: Withdrawn
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: January 3, 2017
• Start date: January 2007

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Drug:
• Pyridoxamine
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Excretion of Oxalate at Highest Dose		4 Weeks	No
Secondary	Change in Urinary Supersaturation		4 Weeks	No