HypophosphatemiaNCT06112236
Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia
An observational study of Hypophosphatemia, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypophosphatemia
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Feb 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung transplant recipient
Who may be able to join
- lung transplant recipient
- treated at the University Hospital Zurich between 2015 until 2022
Who cannot join
- Denied general consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypophosphatemia
- Being tested
- no intervention
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum phosphate level
Change of serum phosphate level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Secondary outcomes (10)
Change of urin phosphate level
Change of urin phosphate level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of hemoglobin
Change of hemoglobin level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of mean corpuscular volume (MCV)
Changes of serum MCV level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of mean corpuscular hemoglobin (MCH)
Change of serum MCH level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of serum magnesium
Change of serum magnesium level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of serum and urin calcium
Change of serum and urin calcium level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Change of serum albumin
Change of serum albumin level before and after iron infusion
Measured: Baseline and up to 90 days after iron infusion
Complications after iron infusion
Number of patients with complications due to hypophosphatemia after iron infusion (Hospitalization, hypoxia, fracture due to hypophosphatemia)
Measured: 2015-2022
Predictors
Analysis of possible predictors for the decrease of serum phosphate levels after iron infusion
Measured: baseline and up to 90 days after iron infusion
Therapeutic management
Descriptive analysis of therapeutic management of hypophosphatemia after iron infusion
Measured: 2015 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start17 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112236
- Sponsor's protocol ID
- 2022-02302
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pumo F, Sievi NA, Gaisl T, Steinack C, Marck L, Hage R, Ulrich S, Schuurmans M, Roeder M. Hypophosphatemia after intravenous ferric carboxymaltose in lung transplant recipients. Intern Emerg Med. 2026 Jul 24. doi: 10.1007/s11739-026-04470-3. Online ahead of print.
PubMed 42498915
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia
- ClinicalTrials.gov ID
- NCT06112236
- Acronym / sponsor ID
- 2022-02302
- Conditions
- Hypophosphatemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung transplant recipient
Key inclusion criteria (2 listed)
- lung transplant recipient
- treated at the University Hospital Zurich between 2015 until 2022
Key exclusion criteria (1 listed)
- Denied general consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
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
10 secondary outcomes
Change of urin phosphate level
Time frame: 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 mean corpuscular volume (MCV)
Time frame: 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 magnesium
Time frame: 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 albumin
Time frame: Baseline and up to 90 days after iron infusion
Complications after iron infusion
Time frame: 2015-2022
Predictors
Time frame: baseline and up to 90 days after iron infusion
Therapeutic management
Time frame: 2015 to 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 42498915Pumo F, Sievi NA, Gaisl T, Steinack C, Marck L, Hage R, Ulrich S, Schuurmans M, Roeder M. Hypophosphatemia after intravenous ferric carboxymaltose in lung transplant recipients. Intern Emerg Med. 2026 Jul 24. doi: 10.1007/s11739-026-04470-3. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Hypophosphatemia
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Study of the Impact of Phosphate Supplementation on FGF23 Concentrations in Patients With Hypophosphatemia
Calcium-phosphorus Metabolism
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Active, not recruitingObservational study
X-linked Hypophosphatemia Disease Monitoring Program
X-linked Hypophosphatemia, Hypophosphatemic Rickets
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypophosphatemia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum phosphate level (time frame: Baseline and up to 90 days after iron infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.