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Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02940860
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects with IDA and NDD-CKD.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anaemia Drug: Iron isomaltoside Drug: Iron Sucrose Phase 3

Detailed Description:

Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes treatment of its underlying cause and restoration of haemoglobin (Hb) concentrations and iron stores.

This study is planned to evaluate the safety and efficacy of iron isomaltoside compared to iron sucrose in subjects with IDA and NDD-CKD.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (FerWonNephro)
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iron isomaltoside (Monofer)
Administered IV
Drug: Iron isomaltoside
Active Comparator: Iron Sucrose (Venofer)
Administered IV
Drug: Iron Sucrose



Primary Outcome Measures :
  1. The-primary safety outcome measure is the incidence of protocol defined hypersensitivity reactions (number of participants with such events) [ Time Frame: 8 weeks ]
  2. The primary efficacy outcome is the ability to increase Hb (g/dL). [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Protocol defined cardiovascular adverse events (number of participants with such events), [ Time Frame: 8 weeks ]
  2. Changes in Ferritin (ng/mL) [ Time Frame: 8 weeks ]
  3. Changes in Transferrin saturation (%) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria includes:

  1. Men or women ≥ 18 years
  2. Hb ≤ 11 g/dL
  3. Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) eGFR < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
  4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if TSAT ≤ 30 %
  5. Either no ESAs or ESAs as a stable dose 4 weeks before randomisation
  6. Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

  1. Anaemia predominantly caused by factors other than IDA
  2. Hemochromatosis or other iron storage disorders
  3. Previous serious hypersensitivity reactions to any IV iron compounds
  4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
  5. Undergoing dialysis for treatment of CKD
  6. Planned surgical procedure within the trial period
  7. Decompensated liver cirrhosis or active hepatitis
  8. Alcohol or drug abuse within the past 6 month.
  9. Pregnant or nursing women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940860


Locations
United States, Florida
Boynton Beach, Florida, United States
Sponsors and Collaborators
Pharmacosmos A/S

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02940860     History of Changes
Other Study ID Numbers: P-Monofer-CKD-04
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics