HypophosphatemiaNCT04502784
Investigation of Hypophosphataemia Following Intravenous Iron
An observational study of Hypophosphatemia and Chronic Kidney Diseases, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypophosphatemia, Chronic Kidney Diseases, Intestinal Disease
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2019to 31 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with intestinal failure or CKD will be recruited from iron infusion clinics, which are based in secondary care. Healthy Volunteers will be recruited from laboratory staff from within the Belfast Health and Social Care Trust
Who may be able to join
- For Patients
- aged 18 years or older
- previously diagnosed with intestinal failure or advanced CKD
- have anaemia requiring administration of intravenous iron
- be able to adequately speak and understand English
- Have capacity to give written informed consent
Show all 10Show fewer
- For Healthy Volunteers
- aged 18 years or more
- be able to adequately speak and understand English
- have capacity to give written informed consent
Who cannot join
- For patients
- have dialysis-dependent CKD
- participation in any other study which will affect results of the current study
- For Healthy Volunteers
- have CKD (eGFR <60 mls/min/1.73^2)
- history of any form of metabolic bone disease
- Participation in any other study which will affect the results of the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Mechanisms for the Development of Hypophosphataemia Following Administration of Intravenous Iron in Patients With Severe Anaemia
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. However, intravenous iron has been associated with the development of low phosphate levels - hypophophosphataemia. The aim of this study is to determine potential causes of hypophosphataemia following administration of intravenous iron.
Read the detailed description
Low levels of iron can lead to anaemia, known as iron deficiency anaemia, which can be debilitating due to symptoms such as shortness of breath, fatigue, and dizziness. Iron deficiency anaemia can be treated by giving iron supplementation. Iron supplements can be taken orally or can be given intravenously (through the veins). Giving iron intravenously has advantages over iron supplements taken orally, which can cause side effects such as stomach pain and cramping. However, giving iron intravenously has been associated with the development of low levels of phosphate in the blood. This is known as hypophosphataemia. Phosphate is an important salt in the body and has a number of important functions. Very low levels of phosphate can cause muscle pain, disorientation, seizures and heart problems. It is unclear why giving iron intravenously can cause hypophosphataemia. This project aims to investigate the potential causes of hypophosphataemia in patients who receive intravenous iron as treatment for anaemia associated with their condition. Patients with chronic kidney disease (CKD) and intestinal failure will be recruited to the study, since people with CKD may handle iron differently than those with healthy kidneys. Samples will be taken at two time points: prior to giving the intravenous iron and at the patient's next appointment. Healthy volunteers will also be recruited to the study to allow comparison between the groups receiving iron and those who do not receive iron. Samples will be analysed to determine potential causes of hypophosphataemia. Results from before and after iron is given will be compared to determine if any of the participants developed hypophosphataemia and if any other test are affected which may explain why this has developed.
- Conditions
- Hypophosphatemia, Chronic Kidney Diseases, Intestinal Disease, Anemia
- Medical subject headings
- Hypophosphatemia, Renal Insufficiency, Chronic, Intestinal Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease | This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia. | |
| Intestinal failure | This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia. | |
| Healthy Volunteers | This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FGF23 levels before and after intravenous iron
Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration
Measured: 8 weeks
Secondary outcomes (2)
FGF23 levels in patients with CKD and healthy volunteers
Comparison of measured FGF23 levels in patients with CKD and healthy volunteers
Measured: 1 week
Characterisation of pre-analytical factors affecting FGF23 levels
To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start7 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brona Roberts, Principal investigator, Beflast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502784
- Sponsor's protocol ID
- 18195BR-SS
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Mechanisms for the Development of Hypophosphataemia Following Administration of Intravenous Iron in Patients With Severe Anaemia
- ClinicalTrials.gov ID
- NCT04502784
- Acronym / sponsor ID
- 18195BR-SS
- Conditions
- Hypophosphatemia, Chronic Kidney Diseases, Intestinal Disease, Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Aug 2020 (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.
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. However, intravenous iron has been associated with the development of low phosphate levels - hypophophosphataemia. The aim of this study is to determine potential causes of hypophosphataemia following administration of intravenous iron.
Detailed description
Low levels of iron can lead to anaemia, known as iron deficiency anaemia, which can be debilitating due to symptoms such as shortness of breath, fatigue, and dizziness. Iron deficiency anaemia can be treated by giving iron supplementation. Iron supplements can be taken orally or can be given intravenously (through the veins). Giving iron intravenously has advantages over iron supplements taken orally, which can cause side effects such as stomach pain and cramping. However, giving iron intravenously has been associated with the development of low levels of phosphate in the blood. This is known as hypophosphataemia. Phosphate is an important salt in the body and has a number of important functions. Very low levels of phosphate can cause muscle pain, disorientation, seizures and heart problems. It is unclear why giving iron intravenously can cause hypophosphataemia. This project aims to investigate the potential causes of hypophosphataemia in patients who receive intravenous iron as treatment for anaemia associated with their condition. Patients with chronic kidney disease (CKD) and intestinal failure will be recruited to the study, since people with CKD may handle iron differently than those with healthy kidneys. Samples will be taken at two time points: prior to giving the intravenous iron and at the patient's next appointment. Healthy volunteers will also be recruited to the study to allow comparison between the groups receiving iron and those who do not receive iron. Samples will be analysed to determine potential causes of hypophosphataemia. Results from before and after iron is given will be compared to determine if any of the participants developed hypophosphataemia and if any other test are affected which may explain why this has developed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | – | –This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia. |
| Intestinal failure | – | –This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia. |
| Healthy Volunteers | – | –This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intestinal failure or CKD will be recruited from iron infusion clinics, which are based in secondary care. Healthy Volunteers will be recruited from laboratory staff from within the Belfast Health and Social Care Trust
Key inclusion criteria (10 listed)
- For Patients
- aged 18 years or older
- previously diagnosed with intestinal failure or advanced CKD
- have anaemia requiring administration of intravenous iron
- be able to adequately speak and understand English
Key exclusion criteria (7 listed)
- For patients
- have dialysis-dependent CKD
- participation in any other study which will affect results of the current study
- For Healthy Volunteers
- have CKD (eGFR <60 mls/min/1.73^2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FGF23 levels before and after intravenous iron
Time frame: 8 weeks
Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration
2 secondary outcomes
FGF23 levels in patients with CKD and healthy volunteers
Time frame: 1 week
Characterisation of pre-analytical factors affecting FGF23 levels
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Brona Roberts principal investigator
Beflast Health and Social Care Trust
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 and Chronic Kidney Diseases, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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 United Kingdom. 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?
Results are not available in the source record.
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?
FGF23 levels before and after intravenous iron (time frame: 8 weeks). 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 6 Aug 2020.