A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01222884
First received: October 15, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).


Condition Intervention Phase
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Drug: Monofer
Drug: Iron sucrose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Ability to maintain haemoglobin level [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hemoglobin concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 352
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iron isomaltoside 1000
Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Drug: Monofer
Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes
Active Comparator: Iron sucrose
Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Drug: Iron sucrose
Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women, aged 18 years or greater.
  2. Subjects diagnosed with CKD-5D and in hemodialysis therapy for at least 90 days.
  3. Life expectancy beyond 12 months by Principal Investigator's judgment.
  4. Willingness and ability to participate after informed consent and any authorization as required by local law.
  5. Hb concentrations between 9.5 g/dL and 12.5 g/dL both at screening and at baseline (screening visit and baseline visit must be separated by at least 1 week).
  6. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to screening.
  7. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4 weeks.

Exclusion Criteria:

  1. Anaemia caused primarily by factors other than renal related anaemia.
  2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
  3. Serum ferritin > 800 ng/ml.
  4. Transferrin Saturation >35%.
  5. Difference between screening Hb and baseline Hb of ≥ 1.0 g/dL.
  6. History of drug hypersensitivity to iron sucrose or iron isomaltoside.
  7. Known hypersensitivity to any excipients in the investigational drug products.
  8. Patients with a history of two or more drug class allergies.
  9. Liver cirrhosis or active hepatitis (alanine aminotransferase (ALT) > 3 times normal).
  10. Acute or chronic infections (assessed by clinical judgment).
  11. Rheumatoid arthritis with symptoms or signs of active inflammation.
  12. Pregnancy or nursing. (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
  13. Blood transfusion within the previous 12 weeks.
  14. Planned elective surgery in the next 8 weeks.
  15. Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives prior to screening.
  16. Untreated vitamin B12 or folate deficiency.
  17. Diagnosis of Hepatitis B and/or C.
  18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222884

Locations
India
Jatin Kothari
Mumbai, India
Sponsors and Collaborators
Pharmacosmos A/S
Investigators
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01222884     History of Changes
Other Study ID Numbers: P-Monofer-CKD-03
Study First Received: October 15, 2010
Last Updated: December 13, 2013
Health Authority: Denmark: Danish Medicines Agency
India: The Drugs Controller General, India
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Switzerland: Swiss Medic
USA: United States Food and Drug Administration
Russia: The Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014