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

NCT ID: NCT00490113

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Pyridoxamine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon I Scheinman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Other Identifiers

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1R21DK072454-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10417

Identifier Type: -

Identifier Source: org_study_id

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