HypophosphatemiaPhase 4IVORYNCT06350955
IV Iron-induced Hypophosphatemia After RYGB
A Phase 4 study testing Iron isomaltoside and Iron Carboxymaltose in people with Hypophosphatemia and Roux-en-Y Gastric Bypass, run by Lucie Favre at 1 site in Switzerland.
Trial summary
The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypophosphatemia, Roux-en-Y Gastric Bypass
- What is being tested?
- Iron isomaltoside and Iron Carboxymaltose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2024to Jun 2026
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Signed informed consent
- Patients with previous RYGB surgery performed > 12 months ago
- Failed response to oral iron supplementation
- Established diagnosis of iron deficiency by ferritin < 50 ug/l or serum ferritin ≤100ug/l and low transferrin saturation (TSAT) ≤ 30%
- Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion
- Normal magnesium blood level (0.65-1.05 mmol/l)
- Outpatient
Who cannot join
- - Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
- Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml/min/1.73m2)
- Patients who received IV iron infusion during the last 3 months before screening
Show all 16Show fewer
- Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening
- Alcohol or drug abuse within the past 6 months
- Planned surgical procedure within the clinical trial period
- Surgery under general anaesthesia within the last 3 months prior to screening
- Hyperparathyroidism
- Kidney transplantation
- Inability to follow study procedures or give informed consent
- Use and inability to stop from V0 to study end, phosphate supplementation (except daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded)
- Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators).
- Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1003
Lucie Favre, MD, +41 21 3140548, lucie.favre@chuv.ch
Sara Santini, MD, sara.santini@chuv.ch
About this study
Official title: Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)
The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).
- Conditions
- Hypophosphatemia, Roux-en-Y Gastric Bypass
- Being tested
- Iron isomaltoside, Iron Carboxymaltose
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltosideDrug
single dose of 500 mg iron isomaltoside
Iron CarboxymaltoseDrug
single dose of 500 mg ferric carboxymaltose
| Study group | Role | What they receive |
|---|---|---|
| Patients with Roux-en-Y gastric bypass and iron deficiency 1 | Experimental | Not described Receives: Drug: Iron isomaltoside |
| Patients with Roux-en-Y gastric bypass and iron deficiency 2 | Experimental | Not described Receives: Drug: Iron Carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypophosphatemia in RYGB patients treated with intravenous iron
Measured: day 14 ± 2, 21 ± 2 and 28 ± 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start2 May 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucie Favre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucie Favre, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350955
- Sponsor's protocol ID
- 2022-01389
- Acronym
- IVORY
- Status last verified
- Aug 2024
- First submitted
- 28 Mar 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)
- ClinicalTrials.gov ID
- NCT06350955
- Acronym / sponsor ID
- IVORY / 2022-01389
- Conditions
- Hypophosphatemia, Roux-en-Y Gastric Bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Lucie FavreUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Apr 2024 (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 primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Roux-en-Y gastric bypass and iron deficiency 1 | Experimental | Drug: Iron isomaltoside |
| Patients with Roux-en-Y gastric bypass and iron deficiency 2 | Experimental | Drug: Iron Carboxymaltose |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients over 18 years
- Signed informed consent
- Patients with previous RYGB surgery performed > 12 months ago
- Failed response to oral iron supplementation
- Established diagnosis of iron deficiency by ferritin < 50 ug/l or serum ferritin ≤100ug/l and low transferrin saturation (TSAT) ≤ 30%
Key exclusion criteria (16 listed)
- - Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
- Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml/min/1.73m2)
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 |
|---|---|---|
| Iron isomaltosidesingle dose of 500 mg iron isomaltoside | Drug | Patients with Roux-en-Y gastric bypass and iron deficiency 1 |
| Iron Carboxymaltosesingle dose of 500 mg ferric carboxymaltose | Drug | Patients with Roux-en-Y gastric bypass and iron deficiency 2 |
Primary outcome
incidence of hypophosphatemia in RYGB patients treated with intravenous iron
Time frame: day 14 ± 2, 21 ± 2 and 28 ± 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron isomaltoside and Iron Carboxymaltose in people with Hypophosphatemia and Roux-en-Y Gastric Bypass, run by Lucie Favre at 1 site in Switzerland.
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 8 inclusion and 16 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 20 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 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypophosphatemia in RYGB patients treated with intravenous iron (time frame: day 14 ± 2, 21 ± 2 and 28 ± 2). 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 20 Aug 2024.