A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria
Sponsor
University of Kansas Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00490113
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
0
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria
Study Start Date
:
Jan 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
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.
|
Outcome Measures
Primary Outcome Measures
- Urinary Excretion of Oxalate at Highest Dose [4 Weeks]
Secondary Outcome Measures
- Change in Urinary Supersaturation [4 Weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Kansas Medical Center
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Jon I Scheinman, M.D., University of Kansas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00490113
Other Study ID Numbers:
- 10417
- 1R21DK072454-02
First Posted:
Jun 22, 2007
Last Update Posted:
Jan 5, 2017
Last Verified:
Jan 1, 2017