NCT00490113

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

First QC Date

June 20, 2007

Last Update Submit

January 3, 2017

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (1)

  • Urinary Excretion of Oxalate at Highest Dose

    4 Weeks

Secondary Outcomes (1)

  • Change in Urinary Supersaturation

    4 Weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Pyridoxamine

Interventions

PyridoxamineDRUG

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Calculi

Interventions

Pyridoxamine

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin B 6PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jon I Scheinman, M.D.

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

January 1, 2007

Last Updated

January 5, 2017

Record last verified: 2017-01