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Trial · NCT07903311

Iron Repletion in Cystic Fibrosis

NCT07903311, Phase 4, Not yet recruiting, University of Michigan

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Iron Repletion in Cystic Fibrosis. Trials, record NCT07903311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903311

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Iron Repletion in Cystic Fibrosis
NCT number
NCT07903311
Status
Not yet recruiting
Phases
Phase 4
Enrollment
100 participants, estimated
Lead sponsor
University of Michigan
Conditions
Cystic Fibrosis, Iron Deficiencies, Iron Deficiency Diseases
Interventions
IV Repletion, PO Repletion
First posted
2026-10-29
Last updated
2026-10-29

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEstimated absolute change in whole blood hemoglobin - ID CohortBaseline, and approximately 3 months
Whole blood hemoglobin in g/dL at 3 months after the start of IV versus PO treatment. Full longitudinal study data from all study visits will be modeled in a linear mixed-effects model which will include time from start of treatment, the treatment (IV versus PO), and interactions between the time and treatment at approximately 1, 3, and 6 months.
SecondaryEstimated absolute change in whole blood hemoglobin - ID CohortBaseline, and approximately 1 and 6 monthsWhole blood hemoglobin in g/dL at 1 and 6 months after the start of IV versus PO treatment will be modeled using approaches described in Outcome 1.
SecondaryEstimated proportion of non-anemic participants - ID CohortBaseline, and approximately 1, 3, and 6 months
Proportion of non-anemic participants over time will be modeled based on an inverse probability weighted generalized estimating equations (GEE) model for the binary variable of hemoglobin value meeting WHO criteria for anemia versus not anemia.
SecondaryEstimated relative change in soluble transferrin receptor (sTfR) - ID CohortBaseline, and approximately 1, 3, and 6 monthsSerum sTfR in % of mg/L at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in transferrin saturation (TSAT) - ID CohortBaseline, and approximately 1, 3, and 6 monthsSerum TSAT in % at 1, 3, and 6 months, determined by total serum iron and iron binding capacity, will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in serum iron - ID CohortBaseline, and approximately 1, 3, and 6 monthsSerum iron in ug/dL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in serum ferritin - ID CohortBaseline, and approximately 1, 3, and 6 monthsSerum ferritin in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in serum ferritin(adj-factor) - ID CohortBaseline, and approximately 1, 3, and 6 monthsAdjusted serum ferritin using the correction factor method for C-reactive protein (CRP) in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in serum ferritin(adj-BRINDA) - ID CohortBaseline, and approximately 1, 3, and 6 monthsAdjusted serum ferritin using the BRINDA method for CRP in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
SecondaryEstimated absolute change in sTfR index - ID CohortBaseline, and approximately 1, 3, and 6 monthssTfR index calculated by sTfR / log (ferritin) at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
K23HL175126Iron Deficiency in Cystic Fibrosis: Characterization of Clinical Impact and Treatment EffectsJIA, SHIJINGUNIVERSITY OF MICHIGAN AT ANN ARBORNATIONAL HEART, LUNG, AND BLOOD INSTITUTE2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07903311

GET https://conductscience.org/api/trials/v1/NCT07903311/registered?page=2