NCT00536666

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

September 27, 2007

Last Update Submit

October 7, 2008

Conditions

Chronic Kidney DiseaseAnemia, Iron-Deficiency

Keywords

Chronic kidney diseaseAneamiaIron oligosaccharideChronic kidney disease patients

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

OTHER

Iron oligosaccharide

Drug: Iron oligosaccharide

Interventions

Iron oligosaccharideDRUG
Also known as: MonoFer
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 three months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Nefrologisk afdeling P

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Soeren Ladefoged, MD, DMSc

    Rigshospitalet, Nefrologisk afdeling P

    PRINCIPAL INVESTIGATOR

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

May 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

DK(1)