Iron Deficiency AnaemiaPhase 3NCT03237065
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
A Phase 3 study testing Iron isomaltoside/ferric derisomaltose and Ferric carboxymaltose in people with Iron Deficiency Anaemia and Iron Deficiency Anemia, run by Pharmacosmos A/S at 15 sites in United States.
Trial summary
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anaemia, Iron Deficiency Anemia
- What is being tested?
- Iron isomaltoside/ferric derisomaltose and Ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Oct 2017to 29 May 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects having IDA caused by different aetiologies
- Haemoglobin (Hb) ≤ 11 g/dL
- Body weight > 50 kg
- Serum ferritin (S-ferritin) < 100 ng/mL
- Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
- Serum phosphate (S-phosphate) > 2.5 mg/dL
- Intolerance or unresponsiveness to oral iron
- Willingness to participate and signing the Informed Consent Form (ICF)
Who cannot join
- Acute bleeding > 500 mL within 72 hours
- Anaemia predominantly caused by factors other than IDA
- Hemochromatosis or other iron storage disorders
- Previous serious hypersensitivity reactions to any IV iron compounds
- Treatment with IV iron within the last 30 days prior to screening
- Treatment with erythropoietin or erythropoietin-stimulation agents
Show all 19Show fewer
- Red blood cell transfusion, radiotherapy, and/or chemotherapy
- Received an investigational drug within the last 30 days prior to screening
- Planned surgical procedure within the trial period
- Hepatic enzymes > 3 times upper limit of normal
- Surgery under anaesthetic within the last 30 days prior to screening
- Any non-viral infection within the last 30 days prior to screening
- Alcohol or drug abuse within the past 6 months
- Vitamin D deficiency
- Untreated hyperparathyroidism
- Kidney transplantation
- Active malignant disease, disease-free for less than 5 years
- History of a psychological illness or seizures
- Pregnant or nursing women.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pharmacosmos Investigational Site
Albuquerque, New Mexico, 87102
Pharmacosmos Investigational Site
Doral, Florida, 33122
Pharmacosmos investigational Site
Flint, Michigan, 48504
Pharmacosmos Investigational Site
Idaho Falls, Idaho, 83404
Pharmacosmos Investigational Site
Las Vegas, Nevada, 89146
Pharmacosmos Investigational Site
Miami, Florida, 33144
Pharmacosmos Investigational Site
Miami, Florida, 33165
Pharmacosmos Investigational Site
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site
Morehead City, North Carolina, 28557
Pharmacosmos Investigational Site
Muscle Shoals, Alabama, 35661
Pharmacosmos Investigational Site
Oak Brook, Illinois, 60523
Pharmacosmos Investigational Site
Orlando, Florida, 32819
Pharmacosmos Investigational Site
Raleigh, North Carolina, 27607
Pharmacosmos Investigational Site
St Louis, Missouri, 63119
Pharmacosmos Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-05)
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
Read the detailed description
This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.
The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia
- Being tested
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Keywords
- Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Iron deficiency, Intravenous iron replacement therapy, Iron isomaltoside, Ferric derisomaltose, Hypophosphatemia, Ferric carboxymaltose, Monofer, Monoferric, Monover, Monofar, Monoferro
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside/ferric derisomaltoseDrug
Also called Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).
Ferric carboxymaltoseDrug
Also called Injectafer®, Ferinject®
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Administered IV Receives: Drug: Iron isomaltoside/ferric derisomaltose |
| Ferric carboxymaltose | Active comparator | Administered IV Receives: Drug: Ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
Safety
The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35.
Measured: Baseline to day 35
Secondary outcomes (16)
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
Safety
Time with hypophosphatemia (i.e. time with s-phosphate level < 2.0 mg/dL) from baseline up to day 35.
The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was <2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.
Measured: Baseline to day 35
Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)
Safety
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35.
Measured: Baseline to day 35
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Safety
Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Safety
Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change From Baseline in Fractional Phosphate Urinary Excretion
Safety
Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.
Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Safety
Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Safety
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Safety
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.
Measured: Baseline to day 35
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Efficacy
Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Efficacy
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Efficacy
Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Measured: Baseline, days 1, 7, 8, 14, 21, and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start30 Oct 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnaemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pharmacosmos A/S Clinical and Non-clinical Research, Study director, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237065
- Sponsor's protocol ID
- P-Monofer-IDA-05
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2017
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3
Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.
PubMed 32016310
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-05)
- ClinicalTrials.gov ID
- NCT03237065
- Acronym / sponsor ID
- P-Monofer-IDA-05
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia
- Keywords
- Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Iron deficiency, Intravenous iron replacement therapy, Iron isomaltoside, Ferric derisomaltose, Hypophosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
Detailed description
This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.
The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Drug: Iron isomaltoside/ferric derisomaltoseAdministered IV |
| Ferric carboxymaltose | Active comparator | Drug: Ferric carboxymaltoseAdministered IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects having IDA caused by different aetiologies
- Haemoglobin (Hb) ≤ 11 g/dL
- Body weight > 50 kg
- Serum ferritin (S-ferritin) < 100 ng/mL
- Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
Key exclusion criteria (19 listed)
- Acute bleeding > 500 mL within 72 hours
- Anaemia predominantly caused by factors other than IDA
- Hemochromatosis or other iron storage disorders
- Previous serious hypersensitivity reactions to any IV iron compounds
- Treatment with IV iron within the last 30 days prior to screening
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 isomaltoside/ferric derisomaltoseAlso: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg). | Drug | Iron isomaltoside/ferric derisomaltose |
| Ferric carboxymaltoseAlso: Injectafer®, Ferinject®Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg). | Drug | Ferric carboxymaltose |
Primary outcome
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
Time frame: Baseline to day 35
Safety The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35.
16 secondary outcomes
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
Time frame: Baseline to day 35
Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)
Time frame: Baseline to day 35
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change From Baseline in Fractional Phosphate Urinary Excretion
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Time frame: Baseline to day 35
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Time frame: Baseline, days 1, 7, 8, 14, 21, and 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationWolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3
- Derived from this study: PubMed 32016310Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.
- 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.
Pharmacosmos A/S Clinical and Non-clinical Research study director
Pharmacosmos A/S
15 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 Iron isomaltoside/ferric derisomaltose and Ferric carboxymaltose in people with Iron Deficiency Anaemia and Iron Deficiency Anemia, run by Pharmacosmos A/S at 15 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 8 inclusion and 19 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) (time frame: Baseline to day 35). 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 NCT03237065, 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 25 Feb 2020.