NCT06112236

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Feb 2023Mar 2027

Study Start

First participant enrolled

February 17, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

June 27, 2023

Last Update Submit

October 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of serum phosphate level

    Change of serum phosphate level before and after iron infusion

    Baseline and up to 90 days after iron infusion

Secondary Outcomes (10)

  • Change of urin phosphate level

    Baseline and up to 90 days after iron infusion

  • Change of hemoglobin

    Baseline and up to 90 days after iron infusion

  • Change of mean corpuscular volume (MCV)

    Baseline and up to 90 days after iron infusion

  • Change of mean corpuscular hemoglobin (MCH)

    Baseline and up to 90 days after iron infusion

  • Change of serum magnesium

    Baseline and up to 90 days after iron infusion

  • +5 more secondary outcomes

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lung transplant recipient

You may qualify if:

  • lung transplant recipient
  • treated at the University Hospital Zurich between 2015 until 2022

You may not qualify if:

  • Denied general consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypophosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

November 1, 2023

Study Start

February 17, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations