A Study of Iron Oligosaccharide in CHF Patients
A Non-Comparative Open-Label Study of Iron Oligosaccharide in CHF Patients With Iron Deficiency (Either Absolute or Functional) Anaemia and a Need for Parenteral Iron
2 other identifiers
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedOctober 8, 2008
October 1, 2008
1.1 years
September 27, 2007
October 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Adverse events (AE) (Number and type of AE)
Eight weeks after enrollment
Serious adverse events (SAEs)
Eight weeks after enrollment
Physical examination
At screening visit and at end of study
Vital signs
At every visit
Clinical laboratory tests (biochemistry, haematology)
At every visit
Secondary Outcomes (1)
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels
At every visit
Study Arms (1)
1
OTHERIron oligosaccharide
Interventions
Eligibility Criteria
You may qualify if:
- Congestive heart failure
- ≥ 18 years of age at screening
- Haemoglobin \< 110 g/L (or 6.8 mmol/L)
- Serum ferritin \< 800 µgram/L
- Life expectancy beyond 12 months
- Willingness to participate after written informed consent
You may not qualify if:
- Non iron deficiency anaemia
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
- Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes)
- Patients with a history of multiple allergies
- Decompensated liver cirrhosis and hepatitis (alanine aminotransferase \> 3 times normal) Acute or chronic infections Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception Active bleeding Planned elective surgery during the study where significant blood loss is expected Participation in any other clinical trial within 3 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacosmos A/Slead
Study Sites (1)
Roskilde University Hospital, Medicinsk afdeling
Roskilde, DK-4000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per Hildebrandt, MD
Roskilde University Hospital, Medicinsk afdeling
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
October 8, 2008
Record last verified: 2008-10