Iron-deficiencyPhase 3EFFECT-KTxNCT03769441
Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation
A Phase 3 study testing Ferric carboxymaltose and Sodium chloride in people with Iron-deficiency and Transplant-Related Disorder, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis. This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency, Transplant-Related Disorder
- What is being tested?
- Ferric carboxymaltose and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Aug 2019to 19 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Kidney transplant recipient
- Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
- At least six months after transplantation at baseline
- Age ≥18 years
- Ability to comply with the study protocol
- Informed consent
Who cannot join
- Intolerance to any intravenous iron solution
- Severe anemia (Hb <10.5 g/dL, <6.5 mmol/L), microcytic anemia (MCV <80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
- A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
- Blood transfusion in the past six weeks
- Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
- Estimated glomerular filtration rate (eGFR) of ≤ 30 ml/min per 1.73 m2
Show all 13Show fewer
- History of haemochromatosis
- Unstable angina or myocardial infarction during the previous month
- Disability to walk
- Severe hypophosphatemia in the month before baseline (serum phosphate <0.35 mmol/L)
- Pregnancy or inability to take adequate contraceptive measures when at childbearing age (women)
- Any signs of an active systemic infection
- Participation in another interventional study
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen, 9713 GZ
University Medical Center Utrecht
Utrecht
About this study
Official title: Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation: a Multicenter Randomized Controlled Trial
Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis.
This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.
Read the detailed description
Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and iron deficiency, treatment with intravenous iron improved exercise capacity and quality of life. Whether such beneficial effects may also occur in kidney transplant recipients is unknown.
Objective: Our main objective is to address whether correction of iron deficiency with ferric(III) carboxymaltose improves exercise tolerance and quality of life in iron-deficient kidney-transplant recipients.
Study design: A multicentre double-blind, placebo-controlled randomized controlled clinical trial will be performed to compare the effects of ferric(III) carboxymaltose with placebo.
Study population: 158 iron-deficient kidney transplant recipients. The intervention arm will receive 10 mL of ferric(III) carboxymaltose (50 mg Fe3/mL, intravenously) every six weeks, with a total of four dosages. The control arm receives an intravenous placebo solution (saline).
Main study parameters/endpoints: The primary endpoint is the distance walked in six minutes, as quantified by the six-minute-walking-test at the end of follow-up.
The investigators expect that iron-deficient kidney transplant recipients will benefit from ferric(III) carboxymaltose treatment as a result of an improvement in exercise tolerance and general wellbeing.
- Conditions
- Iron-deficiency, Transplant-Related Disorder
- Being tested
- Ferric carboxymaltose, Sodium chloride
- Keywords
- Renal Transplantation, Kidney Transplantation, Iron Deficiency
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Four intravenous dosages of ferric(III) carboxymaltose
Sodium chlorideDrug
Also called Placebo
Four intravenous dosages of sodiumchloride
| Study group | Role | What they receive |
|---|---|---|
| Ferric(III) carboxymaltose | Active comparator | The intervention group will be treated with four dosages of 500 mg iron in the form of 10 mL ferric(III) carboxymaltose dissolved in 240 mL of NaCl 0.9%, with interval periods of six weeks. Receives: Drug: Ferric carboxymaltose |
| Placebo | Placebo comparator | The placebo-controlled group will receive four dosages of 250 mL of NaCl 0.9% solution with interval periods of six weeks. Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
The between-group difference in change in exercise tolerance quantified by the six-minute walk test (6MWT)
Measured: 24 weeks
Secondary outcomes (40)
Hemoglobin level
The between-group difference in change in hemoglobin level
Measured: 24 weeks
Iron status
The between-group difference in change in iron parameters (plasma iron, ferritin, transferrin saturation)
Measured: 24 weeks
Cardiac function
The between-group difference in change in cardiac structure, function and strain, analysed with a transthoracic echocardiography
Measured: 24 weeks
Muscle strength 1
The between-group difference in change in muscle strength measured by the 'Five-Times-Sit-to-Stand-test (FTSTS)
Measured: 24 weeks
Muscle strength 2
The between-group difference in change in muscle strength measured by the timed-up-and-Go test (TUG)
Measured: 24 weeks
Muscle strength 3
The between-group difference in change in muscle strength measured by handgrip dynamometry
Measured: 24 weeks
Muscle mass
The between-group difference in change in muscle mass assessed using 24-hour urinary creatinine excretion
Measured: 24 weeks
Phosphate level
The between-group difference in change in phosphate level
Measured: 24 weeks
Calcium level
The between-group difference in change in calcium level
Measured: 24 weeks
Vitamin D status
The between-group difference in change in vitamin D level
Measured: 24 weeks
Parathyroid hormone
The between-group difference in change in parathyroid hormone level level
Measured: 24 weeks
FGF23
The between-group difference in change in FGF23 level
Measured: 24 weeks
Intestinal microbiota
The between-group difference in change in intestinal microbiota
Measured: 24 weeks
Incidence of any infection
The between-group difference in incidence of infections
Measured: 24 weeks
Incidence of hospitalisation
The between-group difference in incidence of hospitalisation
Measured: 24 weeks
Incidence of cardiac events
The between-group difference in incidence of cardiac events
Measured: 24 weeks
Incidence of graft failure
The between-group difference in incidence of graft failure
Measured: 24 weeks
Lymphocyte production of cytokines
The between-group difference in lymphocyte cytokine espression (measured with facs)
Measured: 24 weeks
Lymphocyte production of immunoglobulins
The between-group difference in lymphocyte IgG production (measured with ELISA)
Measured: 24 weeks
Lymphocyte proliferation rate
The between-group difference in lymphocyte proliferation rate (assessed with FACS)
Measured: 24 weeks
B-lymphocyte differentiation rate
The between-group difference in B-lymphocyte plasma cell formation (assessed with Facs)
Measured: 24 weeks
Cognitive performance (memory span)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Digit Span Forward Test, minimum value 0, maximum value 9, a higher score means a better outcome)
Measured: 24 weeks
Cognitive performance (verbal memory)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (15 word test, minimum value 0, maximum value 75, a higher score means a better outcome)
Measured: 24 weeks
Cognitive performance (semantic memory)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Word Fluency Test, minimum value 0, no maximum value, a higher score means a better outcome)
Measured: 24 weeks
Cognitive performance (processing speed)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (symbol digit modalities test, minimum value 0, maximum value 110, a higher score means a better outcome)
Measured: 24 weeks
Cognitive performance (visuomotor and mental speed)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Trail Making Test A, minimum value 1, no maximum value, a lower score means a better outcome)
Measured: 24 weeks
Cognitive performance (cognitive flexibility)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Trail Making Test B, minimum value 1, no maximum value, a lower score means a better outcome)
Measured: 24 weeks
Cognitive performance (executive control)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Controlled Oral Word Association Test, minimum score 1, no maximum score, a higher score means a better outcome)
Measured: 24 weeks
Cognitive performance (working memory)
The between-group difference in change in cognitive performance quantified with neuropsychological testing (Digit Span Backward, minimum score 0, maximum score 8, a higher score means a better outcome)
Measured: 24 weeks
Plasma creatinine
The between-group difference in change in plasma creatinine
Measured: 24 weeks
Quality of Life (health)
The between-group difference in change in quality of life quantified with SF36 questionnaire. A higher score means a better outcome.
Measured: 24 weeks
Quality of Life (subjective fatigue)
The between-group difference in change in quality of life quantified with the Dutch Checklist individual Strength). A higher score means worse fatigue.
Measured: 24 weeks
Quality of Life (long-lasting fatigue)
The between-group difference in change in quality of life quantified with the Dutch Multifactor Fatigue Scale). A higher score means worse fatigue.
Measured: 24 weeks
Quality of Life (overall)
The between-group difference in change in quality of life quantified with EuroQol-5D-5L
Measured: 24 weeks
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination IgG response
The between-group difference in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific antibody titre after vaccination.
Measured: 12 months
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination T-lymphocyte response
The between-group difference in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specif T-lymphocyte response after vaccination.
Measured: 12 months
Gastro-intestinal symptoms
The between-group difference in change in gastro-intestinal symptoms assessed with the gastrointestinal symptom rating scale.
Measured: 24 weeks
Hepatic injury
The between-group difference in change in plasma hepatic enzyme levels (aspartate transaminase and alanine transaminase)
Measured: 24 weeks
Restless legs
The between-group difference in prevalence of restless legs symptoms before and after treatment
Measured: 24 weeks
Kidney graft rejection and injury
The between-group difference in change in urine kidney injury marker levels
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start2 Aug 2019
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a 24 week, multicentre, randomized placebo-controlled clinical trial with two parallel arms to investigate the effect of ferric(III) carboxymaltose on exercise tolerance, cardiac function, skeletal muscle function, quality of life, the gut microbiota and on the immune system, to be performed at the University Medical Center Groningen (UMCG) and the Erasmus MC, University Medical Center Rotterdam.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, Vifor Fresenius Medical Care Renal Pharma
- Responsible party
- Principal investigator, Martin H. de Borst, University Medical Center Groningen
- Investigators
- Martin de Borst, MD/PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769441
- Sponsor's protocol ID
- 201800450
- Acronym
- EFFECT-KTx
- Status last verified
- Aug 2024
- First submitted
- 3 Dec 2018
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To protect participant privacy, public access to the dataset or individual participant data will not be provided. However, after deidentification of these data and after publication of the main results, requests for the re-use of all pseudo-anonymised individual participant data by researchers who provide a methodologically sound proposal for a secondary analysis or meta-analysis will be evaluated by the Principal Investigator. Data may be shared if the research question falls within the scope of the informed consent. Proposals should be directed to m.h.de.borst@umcg.nl and requestors will need to sign a data access agreement.
Publications
Vinke JSJ, Eisenga MF, van der Vaart A, van Lieshout CJ, Dolmans HWGM, van der Meer P, Ter Maaten JM, Spikman JM, Ziengs AL, Kootstra-Ros JE, Nolte IM, Gaillard CGM, de Jong MFC, Berger SP, Sanders JF, Bakker SJL, van Zuilen AD, de Borst MH. Intravenous ferric carboxymaltose and exercise capacity in iron-deficient kidney transplant recipients: a randomised, placebo-controlled trial in the Netherlands. EClinicalMedicine. 2026 Sep 1;99:104169. doi: 10.1016/j.eclinm.2026.104169. eCollection 2026 Sep.
PubMed 42733564Vinke JS, Eisenga MF, Sanders JF, Berger SP, Spikman JM, Abdulahad WH, Bakker SJ, Gaillard CAJM, van Zuilen AD, van der Meer P, de Borst MH. Effect of Intravenous Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation (EFFECT-KTx): rationale and study protocol for a double-blind, randomised, placebo-controlled trial. BMJ Open. 2023 Mar 22;13(3):e065423. doi: 10.1136/bmjopen-2022-065423.
PubMed 36948568
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03769441
- Acronym / sponsor ID
- EFFECT-KTx / 201800450
- Conditions
- Iron-deficiency, Transplant-Related Disorder
- Keywords
- Renal Transplantation, Kidney Transplantation, Iron Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, Vifor Fresenius Medical Care Renal Pharma
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 7 Dec 2018 (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.
Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis.
This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.
Detailed description
Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and iron deficiency, treatment with intravenous iron improved exercise capacity and quality of life. Whether such beneficial effects may also occur in kidney transplant recipients is unknown.
Objective: Our main objective is to address whether correction of iron deficiency with ferric(III) carboxymaltose improves exercise tolerance and quality of life in iron-deficient kidney-transplant recipients.
Study design: A multicentre double-blind, placebo-controlled randomized controlled clinical trial will be performed to compare the effects of ferric(III) carboxymaltose with placebo.
Study population: 158 iron-deficient kidney transplant recipients. The intervention arm will receive 10 mL of ferric(III) carboxymaltose (50 mg Fe3/mL, intravenously) every six weeks, with a total of four dosages. The control arm receives an intravenous placebo solution (saline).
Main study parameters/endpoints: The primary endpoint is the distance walked in six minutes, as quantified by the six-minute-walking-test at the end of follow-up.
The investigators expect that iron-deficient kidney transplant recipients will benefit from ferric(III) carboxymaltose treatment as a result of an improvement in exercise tolerance and general wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a 24 week, multicentre, randomized placebo-controlled clinical trial with two parallel arms to investigate the effect of ferric(III) carboxymaltose on exercise tolerance, cardiac function, skeletal muscle function, quality of life, the gut microbiota and on the immune system, to be performed at the University Medical Center Groningen (UMCG) and the Erasmus MC, University Medical Center Rotterdam.
| Arm | Type | Receives |
|---|---|---|
| Ferric(III) carboxymaltose | Active comparator | Drug: Ferric carboxymaltoseThe intervention group will be treated with four dosages of 500 mg iron in the form of 10 mL ferric(III) carboxymaltose dissolved in 240 mL of NaCl 0.9%, with interval periods of six weeks. |
| Placebo | Placebo comparator | Drug: Sodium chlorideThe placebo-controlled group will receive four dosages of 250 mL of NaCl 0.9% solution with interval periods of six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kidney transplant recipient
- Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
- At least six months after transplantation at baseline
- Age ≥18 years
- Ability to comply with the study protocol
Key exclusion criteria (13 listed)
- Intolerance to any intravenous iron solution
- Severe anemia (Hb <10.5 g/dL, <6.5 mmol/L), microcytic anemia (MCV <80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
- A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
- Blood transfusion in the past six weeks
- Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
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 |
|---|---|---|
| Ferric carboxymaltoseFour intravenous dosages of ferric(III) carboxymaltose | Drug | Ferric(III) carboxymaltose |
| Sodium chlorideAlso: PlaceboFour intravenous dosages of sodiumchloride | Drug | Placebo |
Primary outcome
Exercise tolerance
Time frame: 24 weeks
The between-group difference in change in exercise tolerance quantified by the six-minute walk test (6MWT)
40 secondary outcomes
Hemoglobin level
Time frame: 24 weeks
Iron status
Time frame: 24 weeks
Cardiac function
Time frame: 24 weeks
Muscle strength 1
Time frame: 24 weeks
Muscle strength 2
Time frame: 24 weeks
Muscle strength 3
Time frame: 24 weeks
Muscle mass
Time frame: 24 weeks
Phosphate level
Time frame: 24 weeks
Calcium level
Time frame: 24 weeks
Vitamin D status
Time frame: 24 weeks
Parathyroid hormone
Time frame: 24 weeks
FGF23
Time frame: 24 weeks
Intestinal microbiota
Time frame: 24 weeks
Incidence of any infection
Time frame: 24 weeks
Incidence of hospitalisation
Time frame: 24 weeks
Incidence of cardiac events
Time frame: 24 weeks
Incidence of graft failure
Time frame: 24 weeks
Lymphocyte production of cytokines
Time frame: 24 weeks
Lymphocyte production of immunoglobulins
Time frame: 24 weeks
Lymphocyte proliferation rate
Time frame: 24 weeks
B-lymphocyte differentiation rate
Time frame: 24 weeks
Cognitive performance (memory span)
Time frame: 24 weeks
Cognitive performance (verbal memory)
Time frame: 24 weeks
Cognitive performance (semantic memory)
Time frame: 24 weeks
Cognitive performance (processing speed)
Time frame: 24 weeks
Cognitive performance (visuomotor and mental speed)
Time frame: 24 weeks
Cognitive performance (cognitive flexibility)
Time frame: 24 weeks
Cognitive performance (executive control)
Time frame: 24 weeks
Cognitive performance (working memory)
Time frame: 24 weeks
Plasma creatinine
Time frame: 24 weeks
Quality of Life (health)
Time frame: 24 weeks
Quality of Life (subjective fatigue)
Time frame: 24 weeks
Quality of Life (long-lasting fatigue)
Time frame: 24 weeks
Quality of Life (overall)
Time frame: 24 weeks
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination IgG response
Time frame: 12 months
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination T-lymphocyte response
Time frame: 12 months
Gastro-intestinal symptoms
Time frame: 24 weeks
Hepatic injury
Time frame: 24 weeks
Restless legs
Time frame: 24 weeks
Kidney graft rejection and injury
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42733564Vinke JSJ, Eisenga MF, van der Vaart A, van Lieshout CJ, Dolmans HWGM, van der Meer P, Ter Maaten JM, Spikman JM, Ziengs AL, Kootstra-Ros JE, Nolte IM, Gaillard CGM, de Jong MFC, Berger SP, Sanders JF, Bakker SJL, van Zuilen AD, de Borst MH. Intravenous ferric carboxymaltose and exercise capacity in iron-deficient kidney transplant recipients: a randomised, placebo-controlled trial in the Netherlands. EClinicalMedicine. 2026 Sep 1;99:104169. doi: 10.1016/j.eclinm.2026.104169. eCollection 2026 Sep.
- Derived from this study: PubMed 36948568Vinke JS, Eisenga MF, Sanders JF, Berger SP, Spikman JM, Abdulahad WH, Bakker SJ, Gaillard CAJM, van Zuilen AD, van der Meer P, de Borst MH. Effect of Intravenous Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation (EFFECT-KTx): rationale and study protocol for a double-blind, randomised, placebo-controlled trial. BMJ Open. 2023 Mar 22;13(3):e065423. doi: 10.1136/bmjopen-2022-065423.
- Individual participant dataSharing planned: Yes. To protect participant privacy, public access to the dataset or individual participant data will not be provided. However, after deidentification of these data and after publication of the main results, requests for the re-use of all pseudo-anonymised individual participant data by researchers who provide a methodologically sound proposal for a secondary analysis or meta-analysis will be evaluated by the Principal Investigator. Data may be shared if the research question falls within the scope of the informed consent. Proposals should be directed to m.h.de.borst@umcg.nl and requestors will need to sign a data access agreement.
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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. This study is not recruiting at the moment.
Martin de Borst, MD/PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose and Sodium chloride in people with Iron-deficiency and Transplant-Related Disorder, run by University Medical Center Groningen at 2 sites in Netherlands.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise tolerance (time frame: 24 weeks). 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 NCT03769441, which also lists 2 linked publications.
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 27 Aug 2024.