Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Last updated: September 15, 2020
Sponsor: Pharmacosmos A/S
Overall Status: Completed

Phase

3

Condition

Focal Segmental Glomerulosclerosis

Kidney Disease

Kidney Failure

Treatment

N/A

Clinical Study ID

NCT02940860
P-Monofer-CKD-04
  • Ages > 18
  • All Genders

Study Summary

Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).

Eligibility Criteria

Inclusion

Inclusion Criteria includes:

  1. Men and 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) Estimated Glomerular Filtration Rate (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 Transferrin Saturation (TSAT) ≤ 30 %

  5. Either no Erythropoiesis Stimulating Agent (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.

Study Design

Total Participants: 1538
Study Start date:
November 29, 2016
Estimated Completion Date:
May 29, 2018

Study 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. Therapy of these subjects includes treating the underlying cause of IDA and restoring haemoglobin (Hb) concentration and iron stores.

This study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).

The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.

Connect with a study center

  • Pharmacosmos Investigational Site

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Glendale, California 91206
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Granada Hills, California 91344
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Los Angeles, California 90025
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Lynwood, California 90262
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Montebello, California 90640
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Northridge, California 31324
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Porterville, California 93257
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Rialto, California 92377
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Riverside, California 92505
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Sacramento, California 95825
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    San Dimas, California 91773
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    San Francisco, California 94110
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Tarzana, California 91356
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Arvada, Colorado 80002
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Denver, Colorado 80218
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Westminster, Colorado 80031
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Plainville, Connecticut 06062
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Coral Springs, Florida 33071
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Doral, Florida 33166
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Pharmacosmos Investigational Site3

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Homestead, Florida 33030
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Lake City, Florida 32024
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Lauderdale Lakes, Florida 33313
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Lauderdale Lakes, Florida 33313
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Miami, Florida 33135
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Miami, Florida 33165
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Miami, Florida 33165
    United States

    Site Not Available

  • Pharmacosmos Investigational Site3

    Miami, Florida 33145
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Naples, Florida 34102
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Plantation, Florida 33322
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Saint Petersburg, Florida 33713
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Tampa, Florida 33614
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Tampa, Florida 33607
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Tampa, Florida 33607
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    W. Miami, Florida 33144
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Augusta, Georgia 30901
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Chicago, Illinois 60643
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Crystal Lake, Illinois 60012
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Fort Wayne, Indiana 48604
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Marion, Indiana 46952
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Florissant, Missouri 63031
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Flushing, New York 11355
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Bethlehem, Pennsylvania 18107
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Austin, Texas 78758
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    El Paso, Texas 79935
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Greenville, Texas 75401
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Houston, Texas 77084
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    Houston, Texas 77030
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    Houston, Texas 77099
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Lufkin, Texas 75904
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Pearland, Texas 77581
    United States

    Site Not Available

  • Pharmacosmos Investigational Site1

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Pharmacosmos Investigational Site2

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Arlington, Virginia 22207
    United States

    Site Not Available

  • Pharmacosmos Investigational Site

    Fairfax, Virginia 22033
    United States

    Site Not Available

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