Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
338
Countries
1
Sites
5
Anemia
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in quality o…
Key facts
- Sponsor
- Region Uppsala
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Sep 2024 → ongoing
- Decision date (initial)
- 2024-03-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Vifor Pharma
External identifiers
- EU CT number
- 2022-502776-22-00
- ClinicalTrials.gov
- NCT05744219
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in quality of life five weeks post operatively using FACT-An QoL questionnaire
Secondary objectives 7
- If the intervention affect levels of post operative Hb, and if this is linked to recovery and performance status until five weeks post operatively
- If the intervention affect complication rate after surgery including re-interventions and re-admissions to hospital
- If the intervention affect recovery to such a degree that it improves the chance of receiving systemic oncological treatment incase of malignant disease
- If the intervention affect the risk of adverse cardiovascular events following primarily complex aortic repair, including spinal ischemia
- Short- and long-term effects of iv Ferric Carboxymaltose in subgroups according to; Sex, Comorbidity, Type of surgery, Peri-operative blood loss and Pre-operative anaemia and iron deficiency.
- To assess immediate- and short-term risks of post-operative Ferric Carboxymaltose on hypersensitivity reactions, infections, hypophosphatemia, thromboembolic events and liver function.
- To assess long term effects on morbidity, mortality and recurrence of oncological disease.
Conditions and MedDRA coding
Anemia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Provision of written informed consent
- Male and female participants
- Weight > 50 kg
- > 18 years of age
- Scheduled for complex aortic surgery, liver resection or pancreatic resection
Exclusion criteria 11
- Short expected survival (less than six months)
- Intra-venous iron therapy within one month prior to surgery
- Severe anaemia (B-Hb <80 mg/L) prior to surgery
- Contraindication to Ferric Carboxymaltose according to SmPC
- Iron overloading disorder, i.e. hemochromatosis
- Risk of small for size future liver remnant
- Pre-operative renal replacement therapy
- Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
- Another planned major surgical procedure before the five week follow up
- Unsuitable for inclusion according to the investigator
- Pregnancy or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery. The composite endpoint is assessed by win ratio in the order given above.
Secondary endpoints 7
- If the intervention affects levels of post operative Hb, and if this is linked to the primary outcome and affects early post operative recovery and performance status five weeks after surgery.
- If the intervention affects complication rate after surgery, re-admissions to hospital after discharge and re-interventions after primary surgery. Analysed 1 year after surgery.
- If the intervention affects chance of receiving systemic oncological therapy in case of malignant disease. Follow-up 1 year after surgery.
- If the intervention affects rate of spinal ischemia after complex aortic repair. Follow-up 1 year after surgery.
- Effects of Ferric Carboxymaltose between 5 weeks to 5 years after surgery in different subgroups.
- Number of adverse events reported during administration of Ferric Carboxymaltose iv and during the 5-week follow-up after surgery.
- Morbidity, mortality and recurrence of oncological disease reported during the 5-year follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
-
B03AC · Product
- Pharmaceutical form
- PHF00230MIG
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B03AC — IRON TRIVALENT, PARENTERAL PREPARATIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SCP1023586 · ATC
- Active substance
- Mannitol
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Uppsala
- Sponsor organisation
- Region Uppsala
- Address
- Storgatan 27, Uppsala Domkyrkofors. Uppsala Domkyrkofors.
- City
- Uppsala
- Postcode
- 753 31
- Country
- Sweden
Scientific contact point
- Organisation
- Region Uppsala
- Contact name
- Department of Surgery, Jon Unosson
Public contact point
- Organisation
- Region Uppsala
- Contact name
- Department of Surgery, Jon Unosson
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 338 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Uppsala University Hospital
VO Kirurgi, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
HPB Kirurgi, Kirurgiska kliniken, SUS, Entregatan 7, 222 42, Lund
Region Vaesterbotten
Norrlands Universitetssjukhus (NUS), Kirurgcentrum, Koksvagen 11, Alidhem, Umea
Linkoping University Hospital Region Ostergotland
Department of Surgery, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Vaermland
Centralsjukhuset Karlstad, Kirurgkliniken, Rosenborgsgatan 50, 652 33, Karlstad
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-09-05 | 2024-09-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Sweden | Acceptable 2024-03-12
|
2024-03-13 |