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

January 3, 2017 updated by: University of Kansas Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Urinary Supersaturation
Time Frame: 4 Weeks
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Jon I Scheinman, M.D., University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10417 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • 1R21DK072454-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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