A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
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Purpose
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with chronic kidney disease with a need for parenteral iron.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Anemia, Iron-Deficiency |
Drug: Iron oligosaccharide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron |
- Adverse events (AE) (Number and type of AE) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
- Serious adverse events (SAEs) [ Time Frame: Eight weeks after enrollment ] [ Designated as safety issue: Yes ]
- Physical examination [ Time Frame: At screening visit and at end of study ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests (biochemistry, haematology) [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
- Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels [ Time Frame: At every visit ] [ Designated as safety issue: No ]
| Enrollment: | 182 |
| Study Start Date: | May 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Iron oligosaccharide
|
Drug: Iron oligosaccharide
Other Name: MonoFer
|
Detailed Description:
Iron dextrans have been marketed for more than 50 years and the compiled preclinical and clinical experience with iron dextrans in general is well established. Pharmacosmos A/S already markets the iron dextran CosmoFer® worldwide, except in the US where the product is named INFeD®. A new iron oligosaccharide has been manufactured by Pharmacosmos A/S and it is a further development of CosmoFer® where ferric hydroxide has been combined with low molecular weight oligosaccharides in a relatively strong complex. This iron carbohydrate complex builds on the well established efficacy and safety profile of existing iron dextran but with a significantly reduced anaphylactic potential.
In order to ensure that iron oligosaccharide will not lead to unexpected adverse events the existing clinical information on iron dextrans in general needs to be supplied with clinical safety data from a limited number of relevant patients exposed to iron oligosaccharide in open label non-comparator studies.
The primary objective of the present study is to obtain such safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for correction/maintenance therapy of anaemia in patients with chronic kidney disease with a need for parenteral iron due to either absolute or functional iron deficiency anaemia.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Chronic kidney disease patients in pre-dialysis or undergoing dialysis not currently treated with parenteral iron may be included if they meet the following criteria:
- ≥ 18 years of age at screening
- Hb < 110 g/L (6.8 mmol/L)
- Serum ferritin < 800 µgram/L
- Life expectancy beyond 12 months
- Willingness to participate after written informed consent
Chronic kidney disease patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to iron oligosaccharide may be included if they meet the following criteria:
- ≥ 18 years of age at screening
- Hb ≤ 130 g/L
- Serum ferritin > 200 µgram/L but < 800 µgram/L
- Life expectancy beyond 12 months
- Willingness to participate after written informed consent
Exclusion Criteria:
- 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 three months prior to screening
Contacts and Locations| Denmark | |
| Rigshospitalet, Nefrologisk afdeling P | |
| Copenhagen, Denmark, DK-2100 | |
| Principal Investigator: | Soeren Ladefoged, MD, DMSc | Rigshospitalet, Nefrologisk afdeling P |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00536666 History of Changes |
| Other Study ID Numbers: | P-CKD-01, EudraCT No.: 2007-000765-37 |
| Study First Received: | September 27, 2007 |
| Last Updated: | October 7, 2008 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee Sweden: Medical Products Agency Sweden: Regional Ethical Review Board United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by Pharmacosmos A/S:
|
Chronic kidney disease Aneamia Iron oligosaccharide Chronic kidney disease patients |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Anemia, Iron-Deficiency Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases Urologic Diseases Anemia, Hypochromic Iron Metabolism Disorders |
Metabolic Diseases Renal Insufficiency Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013