A Phase 3 interventional study of Ferric Derisomaltose Injection and Normal saline in Gynecologic Cancer, Anemia, Iron Deficiency and Surgery, sponsored by Alberta Health Services, Calgary. Status unknown. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Alberta Health Services, Calgary · Phase 3, Interventional, and Treatment
Among 32 studies testing iron isomaltoside 1000 in Anemia, Iron-Deficiency — 9 open to participants now, 9 under way, 4 of them phase 3. iron isomaltoside 1000 · Anemia, Iron-Deficiency.
Among the 32 studies testing iron isomaltoside 1000 in Anemia, Iron-Deficiency, this one is the 23rd largest by planned enrollment, is one of 2 that started in 2022, is one of 18 in phase 3, and was the 27th registered.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
Browse Anemia, Iron-Deficiency studies →9 of the 32 studies testing iron isomaltoside 1000 in Anemia, Iron-Deficiency are open now, in 6 countries. Recruiting first, the newest first:
Sichuan Huiyu Pharmaceutical Co., Ltd · Sites in China
Hull University Teaching Hospitals NHS Trust · Sites in United Kingdom
AHS Cancer Control Alberta · Sites in Canada
Children's Hospital Los Angeles · Sites in United States
Sun Yat-sen University · Sites in China
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 19 · Phase 4 7
First in 2007; this study’s year is marked. 2 started in 2022.
This study's planned enrollment of 82 is below the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Median enrollment 121 across the 32 interventional studies. Of the 19 that completed or were terminated, 8 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 32 have an industry lead sponsor. The 10 most frequent:
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Alberta Health Services, Calgary has 1 study filed under Anemia, Iron-Deficiency — fewer than ten, so there is no comparison to draw.
3 of the studies testing iron isomaltoside 1000 in Anemia, Iron-Deficiency that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05462704Phase 3Women and Infants Hospital of Rhode IslandIntravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy | 2027-03-30 |
| NCT06884280Phase 3Hull University Teaching Hospitals NHS TrustComparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study | 2027-10 |
| NCT04913649dr. P. NoordzijIntravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients | 2026-11 |
Among the 32 studies testing iron isomaltoside 1000 in Anemia, Iron-Deficiency, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
Drug: Ferric Derisomaltose Injection
100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
Drug: Normal saline
1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
Also known as: iron isomaltoside, Monoferric, Monofer
100 mL of 0.9% normal saline (w/v) by intravenous infusion
Preoperative hemoglobin level
Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
Time frame: 0 to 3 days prior to planned surgical intervention
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Sep 2023, 12 months later.
Of 48 phase 3 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron isomaltoside 1000
Alberta Health Services, Calgary