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

This study has been withdrawn prior to enrollment.
(Drug unavailable)
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00490113
First received: June 20, 2007
Last updated: September 21, 2015
Last verified: September 2015

June 20, 2007
September 21, 2015
January 2007
Not Provided
Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ]
Complete list of historical versions of study NCT00490113 on ClinicalTrials.gov Archive Site
Change in Urinary Supersaturation [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change in Urinary Supersaturation [ Time Frame: 4 Weeks ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Kidney Stones
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.
Experimental: 1
Intervention: Drug: Pyridoxamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00490113
10417, 1R21DK072454-02
Yes
Not Provided
Not Provided
Jon I Scheinman, M.D., University of Kansas Medical Center
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jon I Scheinman, M.D. University of Kansas Medical Center
University of Kansas Medical Center
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP