A Trial of Pyridoxamine to Lower Urine Oxalate in Subject... | NCT00490113

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

NCT00490113

Sponsor

University of Kansas Medical Center

Status

Withdrawn

Last Update Posted

Jan 5, 2017Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Kidney Stones

Interventions

Pyridoxamine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21DK072454-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drug unavailable

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 21, 2007

First Posted Date

Jun 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2017

Last Update Posted Date

Jan 5, 2017Estimated

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Pyridoxamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pyridoxamine	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.

Measure	Description	Time Frame
Urinary Excretion of Oxalate at Highest Dose		4 Weeks

Measure	Description	Time Frame
Change in Urinary Supersaturation		4 Weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jon I Scheinman, M.D.	University of Kansas Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011733	Pyridoxamine

Ancestor Terms

ID	Term
D025101	Vitamin B 6
D010847	Picolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided