- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119765
Plasma Oxalate in Patient With Short Bowel (OXAGO)
July 20, 2022 updated by: Hospices Civils de Lyon
Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis.
Not all patients are prone to these renal complications.
only urinary oxaluria is measured in practice.
Plasma oxalate shouldn't increase theoretically in these patients.
However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria.
The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Nephrology Department, Edouard Herriot Hospital
-
-
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
Sampling Method
Non-Probability Sample
Study Population
type II short bowel patient
Description
Inclusion Criteria:
- Age ≥ 18 years
- Type II short bowel for more than 6 months
- Affiliated to a social health care
Exclusion Criteria:
- Primary hyperoxaluria
- Other type of short bowel than type II
- Minor patient or major patient protected by the law
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma oxalate rate (oxalemia)
Time Frame: at inclusion
|
this sample measures the plasma oxalate rate
|
at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandrine Lemoine, MD, Hospices Civils de Lyon
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 (Actual)
February 27, 2020
Primary Completion (Actual)
May 4, 2022
Study Completion (Actual)
May 4, 2022
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0408
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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