- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112236
Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia
October 26, 2023 updated by: University of Zurich
The aim of this study is to generate evidence regarding hypophosphatemia after iron infusion in lung transplant recipients in context of anemia and/or iron deficiency.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
250
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
-
-
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Zurich, Switzerland, 8091
- University Hospital Zürich
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
lung transplant recipient
Description
Inclusion Criteria:
- lung transplant recipient
- treated at the University Hospital Zurich between 2015 until 2022
Exclusion Criteria:
- Denied general consent
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of serum phosphate level
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of serum phosphate level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of urin phosphate level
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of urin phosphate level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of hemoglobin
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of hemoglobin level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of mean corpuscular volume (MCV)
Time Frame: Baseline and up to 90 days after iron infusion
|
Changes of serum MCV level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of mean corpuscular hemoglobin (MCH)
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of serum MCH level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of serum magnesium
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of serum magnesium level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of serum and urin calcium
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of serum and urin calcium level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Change of serum albumin
Time Frame: Baseline and up to 90 days after iron infusion
|
Change of serum albumin level before and after iron infusion
|
Baseline and up to 90 days after iron infusion
|
Complications after iron infusion
Time Frame: 2015-2022
|
Number of patients with complications due to hypophosphatemia after iron infusion (Hospitalization, hypoxia, fracture due to hypophosphatemia)
|
2015-2022
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Predictors
Time Frame: baseline and up to 90 days after iron infusion
|
Analysis of possible predictors for the decrease of serum phosphate levels after iron infusion
|
baseline and up to 90 days after iron infusion
|
Therapeutic management
Time Frame: 2015 to 2022
|
Descriptive analysis of therapeutic management of hypophosphatemia after iron infusion
|
2015 to 2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 17, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
June 27, 2023
First Submitted That Met QC Criteria
October 26, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-02302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Hypophosphatemia
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University Hospital, Clermont-FerrandDiaSorin ; Saluggia, ItaliaCompletedHypophosphatemia Without Immediate Anteriority | Unexplained HypophosphatemiaFrance
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University Hospital, GenevaCompletedIron Induced HypophosphatemiaSwitzerland
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Ayman Anis MetryCompletedEffect of Hypophosphatemia on Septic PatientsEgypt
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Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-Linked HypophosphatemiaUnited States
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Kyowa Kirin Pharmaceutical Development LtdActive, not recruitingX-Linked HypophosphatemiaSpain, Italy, United Kingdom, France, Belgium, Denmark, Germany, Hungary, Portugal, Norway, Switzerland, Israel, Netherlands, Czechia, Bulgaria, Sweden, Slovenia, Ireland, Latvia, Slovakia
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Kyowa Kirin Pharmaceutical Development LtdRecruitingX-Linked HypophosphatemiaFrance, Netherlands, United Kingdom
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Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-Linked HypophosphatemiaKorea, Republic of, Canada, United States, Australia, Japan, United Kingdom, Sweden
-
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