Cystic FibrosisPhase 4NCT07903311
Iron Repletion in Cystic Fibrosis
A Phase 4 study testing IV Repletion and PO Repletion in people with Cystic Fibrosis and Iron Deficiencies, run by University of Michigan at 8 sites in United States.
Trial summary
The researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Iron Deficiencies, Iron Deficiency Diseases
- What is being tested?
- IV Repletion and PO Repletion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2026to Apr 2030
- Phase
- Phase 4
- 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
Who may be able to join
- A CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and at least one of the following criteria:
- sweat chloride ≥ 60 milliequivalent/liter by quantitative pilocarpine iontophoresis test (QPIT)
- two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- abnormal nasal potential difference (NPD, change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV)
- Ability to provide written informed consent and to comply with the requirements of the study
- --------------------------------------------------
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- Additional Inclusion Criteria for ID Cohort:
- ID defined by at least one of the following criteria:
- Both of the following: i. transferrin saturation (TSAT) < 20% OR ferritin < 30 ug/L ii. hemoglobin < 12.0 g/dL in female OR hemoglobin < 13.0 g/dL in male per World Health Organization (WHO) anemia definition b. TSAT < 15% or ferritin < 15 ug/L irrespective of hemoglobin value
- --------------------------------------------------
- Additional Inclusion Criteria for Borderline ID Cohort:
- Borderline ID defined by both of the following criteria:
- TSAT < 20% OR ferritin < 60 ug/L
- not meeting ID Cohort criteria above
- --------------------------------------------------
Who cannot join
- Treated with IV repletion within 3 months of Screening Visit
- Treated with PO repletion within 1 months of Screening Visit
- Treated with red blood cell (RBC) transfusion within 3 months of Screening Visit
- Known allergy to either IV or PO iron for ID Cohort, or known allergy to PO iron for Borderline ID Cohort
- Prior solid organ or hematologic transplant
- Hemodialysis dependent within 6 months of Screening Visit, active use of erythropoiesis stimulating agent at time of Screening Visit, or Glomerular Filtration Rate (GFR) < 45 estimated based on creatinine (CKD-EPI 2021) at time of Screening Visit
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- Use of extracorporeal organ support (ECOS) of any type, including but not limited to extracorporeal membrane oxygenation (ECMO), within 6 months of Screening Visit
- Pregnant, or within 3 months of a prior pregnancy at Screening Visit
- Presence of known cause of anemia other than ID that has required treatment within 12 months of Screening Visit
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Shijing Jia, MD, 734-936-8917, sjia@med.umich.edu
Shijing Jia, MD
Medical University of South Carolina
Charleston, South Carolina, 29425
Christina Email: Mingora, 843-792-9200, mingora@musc.edu
Christina Mingora
National Jewish Health
Denver, Colorado, 80206
Alix Wilson, 303-270-2517, wilsona@njhealth.org
Jennifer Taylor
Indiana University
Indianapolis, Indiana, 46202
Heather Kirchner, 317-278-0062, hekinney@iu.edu
Courtney Vujakovich, 317-278-3051, cvujakov@iu.edu
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Larry Scott, 913-588-4020, Lscott2@kumc.edu
Joel Mermis
University of Minnesota
Minneapolis, Minnesota, 55455
Brooke Noren, 612-625-7995, boer0039@umn.edu
Sarah Kiel, MD
Columbia University Irving Medical Center
New York, New York, 10032
Jordan Rhodeman, 212-305-4675, Jar2403@cumc.columbia.edu
Claire Keating, MD
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6450
Michel Wehrli-Veit, 402-559-7585, michel.veit@unmc.edu
About this study
Official title: A Multicenter Trial of Iron Repletion in Cystic Fibrosis: IRON-CF
The researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures.
Read the detailed description
Participants with cystic fibrosis (CF) will be enrolled in this study. Approximately 80 participants will be enrolled in the Iron Deficient (ID) Cohort; and approximately 20 participants will be enrolled in the Borderline ID Cohort. Participants enrolled in the ID Cohort will be randomized to either an IV versus PO route of iron repletion. Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion. The focus of the study is the ID Cohort; the Borderline ID Cohort is exploratory.
- Conditions
- Cystic Fibrosis, Iron Deficiencies, Iron Deficiency Diseases
- Being tested
- IV Repletion, PO Repletion
- Medical subject headings
- Cystic Fibrosis, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV RepletionDrug
Possible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: low molecular weight iron dextran; ferric carboxymaltose; ferric derisomaltose.
PO RepletionDrug
Possible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: ferrous sulfate (325 mg/65 mg elemental iron every other day).
| Study group | Role | What they receive |
|---|---|---|
| Iron Deficient IV | Experimental | Participants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the IV route of administration. Receives: Drug: IV Repletion |
| Iron Deficient PO | Experimental | Participants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration. Receives: Drug: PO Repletion |
| Borderline Iron Deficient PO | Experimental | Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion in a 1:1 ratio. Participants are not randomized to a specific drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration. Receives: Drug: PO Repletion |
| Borderline Iron Deficient Usual Care | No intervention | Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion in a 1:1 ratio. Usual care is defined as continued clinical care as usual without a specific plan to replete iron. This arm is randomized to usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated absolute change in whole blood hemoglobin - ID Cohort
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.
Measured: Baseline, and approximately 3 months
Secondary outcomes (20)
Estimated absolute change in whole blood hemoglobin - ID Cohort
Whole 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.
Measured: Baseline, and approximately 1 and 6 months
Estimated proportion of non-anemic participants - ID Cohort
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.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated relative change in soluble transferrin receptor (sTfR) - ID Cohort
Serum sTfR in % of mg/L at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in transferrin saturation (TSAT) - ID Cohort
Serum 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.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum iron - ID Cohort
Serum iron in ug/dL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin - ID Cohort
Serum ferritin in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin(adj-factor) - ID Cohort
Adjusted 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.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin(adj-BRINDA) - ID Cohort
Adjusted 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.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in sTfR index - ID Cohort
sTfR index calculated by sTfR / log (ferritin) at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in whole blood red blood cell (RBC) mean corpuscular volume (MCV) - ID cohort
RBC MCV in fL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in 6-minute walk distance (6MWD) - ID Cohort
6MWD in meters at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated change in percent predicted forced expiratory volume in the first second (ppFEV1) - ID Cohort
ppFEV1 measured by spirometry in % at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in hand grip strength - ID Cohort
Hand grip strength in lbs, assessed using the Jamar dynamometer, at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in body mass index (BMI) - ID Cohort
BMI measured by height and weight in kg/m2 at 1, 3, and 6 months will be modeled using approaches described in Outcome 1.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in fatigue severity score (FSS) - ID Cohort
FSS at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. The FSS is a 9 question scale, with raw score range of 9-63, and final score range of 1-7, with higher scores indicating more fatigue.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in cystic fibrosis questionnaire revised (CFQ-R) - ID Cohort
CFQ-R scores captured using the ≥ 14 years of age questionnaire at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. The CFQ-R is reported in separate domains, with a score range of 0-100 for each domain, with higher scores indication better health-related quality of life.
Measured: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in gastrointestinal symptom score (GI-SS) - ID Cohort
Total number of present GI symptoms, out of 8 total assessed in Section C of the questionnaire, at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. Additionally, numerical severity of symptoms will be modeled (0=absent, 1=mild, 2=moderate, 3=severe) using the same approach. A higher number indicates more severe GI symptoms.
Measured: Baseline, and approximately 1, 3, and 6 months
Time to next distal intestinal obstruction syndrome (DIOS) event - ID Cohort
All unique DIOS events which occur from start of IV versus PO treatment through the duration of follow-up will be modeled using the Xia/Murray/Tayob method, which is a robust multivariable restricted time model with the capacity to analyze repeated time-to-event data throughout the study period.
Measured: Start of treatment through the approximate 6-month study period
Time to next pulmonary exacerbation (PEx) - ID Cohort
All unique PEx events which occur from start of IV versus PO treatment through the duration of follow-up will be modeled using the Xia/Murray/Tayob method, which is a robust multivariable restricted time model with the capacity to analyze repeated time-to-event data throughout the study period.
Measured: Start of treatment through the approximate 6-month study period
Adherence - ID Cohort
Adherence to treatment will be defined as cumulative % of doses of respect treatment arm estimated over the study period relative to the total prescribed doses. Adherence to IV versus PO iron treatment as a % will be analyzed by 2-sample t-test.
Measured: Start of treatment through the approximate 6-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Shijing Jia, University of Michigan
- Investigators
- Shijing Jia, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903311
- Sponsor's protocol ID
- HUM00285284
- Other IDs
- K23HL175126
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected, generated, and used in this research study will be preserved and shared, exclusive of data for which we do not have participant consent or IRB approval (e.g., data which may be used to identify individual patients). Deidentified study data will be maintained and shared to aid in future validation of the study results, accelerate future potential research in the field.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial of Iron Repletion in Cystic Fibrosis: IRON-CF
- ClinicalTrials.gov ID
- NCT07903311
- Acronym / sponsor ID
- HUM00285284
- Conditions
- Cystic Fibrosis, Iron Deficiencies, Iron Deficiency Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 29 Oct 2026 (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 researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures.
Detailed description
Participants with cystic fibrosis (CF) will be enrolled in this study. Approximately 80 participants will be enrolled in the Iron Deficient (ID) Cohort; and approximately 20 participants will be enrolled in the Borderline ID Cohort. Participants enrolled in the ID Cohort will be randomized to either an IV versus PO route of iron repletion. Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion. The focus of the study is the ID Cohort; the Borderline ID Cohort is exploratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iron Deficient IV | Experimental | Drug: IV RepletionParticipants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the IV route of administration. |
| Iron Deficient PO | Experimental | Drug: PO RepletionParticipants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration. |
| Borderline Iron Deficient PO | Experimental | Drug: PO RepletionParticipants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion in a 1:1 ratio. Participants are not randomized to a specific drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration. |
| Borderline Iron Deficient Usual Care | No intervention | –Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion in a 1:1 ratio. Usual care is defined as continued clinical care as usual without a specific plan to replete iron. This arm is randomized to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and at least one of the following criteria:
- Ability to provide written informed consent and to comply with the requirements of the study
- --------------------------------------------------
- ID defined by at least one of the following criteria:
- --------------------------------------------------
Key exclusion criteria (10 listed)
- Treated with IV repletion within 3 months of Screening Visit
- Treated with PO repletion within 1 months of Screening Visit
- Treated with red blood cell (RBC) transfusion within 3 months of Screening Visit
- Known allergy to either IV or PO iron for ID Cohort, or known allergy to PO iron for Borderline ID Cohort
- Prior solid organ or hematologic transplant
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 |
|---|---|---|
| IV RepletionPossible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: low molecular weight iron dextran; ferric carboxymaltose; ferric derisomaltose. | Drug | Iron Deficient IV |
| PO RepletionPossible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: ferrous sulfate (325 mg/65 mg elemental iron every other day). | Drug | Borderline Iron Deficient PO, Iron Deficient PO |
Primary outcome
Estimated absolute change in whole blood hemoglobin - ID Cohort
Time frame: Baseline, 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.
20 secondary outcomes
Estimated absolute change in whole blood hemoglobin - ID Cohort
Time frame: Baseline, and approximately 1 and 6 months
Estimated proportion of non-anemic participants - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated relative change in soluble transferrin receptor (sTfR) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in transferrin saturation (TSAT) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum iron - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin(adj-factor) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in serum ferritin(adj-BRINDA) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in sTfR index - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in whole blood red blood cell (RBC) mean corpuscular volume (MCV) - ID cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in 6-minute walk distance (6MWD) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated change in percent predicted forced expiratory volume in the first second (ppFEV1) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in hand grip strength - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in body mass index (BMI) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in fatigue severity score (FSS) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in cystic fibrosis questionnaire revised (CFQ-R) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Estimated absolute change in gastrointestinal symptom score (GI-SS) - ID Cohort
Time frame: Baseline, and approximately 1, 3, and 6 months
Time to next distal intestinal obstruction syndrome (DIOS) event - ID Cohort
Time frame: Start of treatment through the approximate 6-month study period
Time to next pulmonary exacerbation (PEx) - ID Cohort
Time frame: Start of treatment through the approximate 6-month study period
Adherence - ID Cohort
Time frame: Start of treatment through the approximate 6-month study period
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. All data collected, generated, and used in this research study will be preserved and shared, exclusive of data for which we do not have participant consent or IRB approval (e.g., data which may be used to identify individual patients). Deidentified study data will be maintained and shared to aid in future validation of the study results, accelerate future potential research in the field.
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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.
Shijing Jia, MD principal investigator
University of Michigan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Repletion and PO Repletion in people with Cystic Fibrosis and Iron Deficiencies, run by University of Michigan at 8 sites in United States.
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 15 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shijing Jia, MD (734-936-8917, sjia@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated absolute change in whole blood hemoglobin - ID Cohort (time frame: Baseline, and approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.