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

NCT02940860 | Completed Phase 3 Results DMC

• 1 other identifier: P-Monofer-CKD-04
• Study Type: interventional
• Target: 1,538
• Locations: 1 country
• Sites: 141

Brief 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).

Conditions

Iron Deficiency Anaemia; Iron Deficiency Anemia; Chronic Kidney Disease

Keywords

Iron Deficiency Anaemia; Iron Deficiency Anemia; IDA; Chronic Kidney Disease; CKD; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin (Hb) From Baseline to Week 8

  Efficacy Evaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA). Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.

  Baseline to week 8

• Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

  Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.

  Baseline to week 8

Secondary Outcomes (18)

• Composite Cardiovascular Adverse Events (AEs)

  Baseline, week 1, 2, and 8

• Time to First Composite Cardiovascular Safety AE

  Baseline, week 1, 2, 4, and 8

• S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

  Baseline, week 1, 2, 4, and 8

• Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8

  Baseline, week 1, 2, 4, and 8

• Time to Change in Hb Concentration ≥1 g/dL

  Baseline, week 1, 2, 4, and 8

Study Arms (2)

Iron isomaltoside/ferric derisomaltose

EXPERIMENTAL

Administered IV

Drug: Iron isomaltoside/ferric derisomaltose

Iron sucrose

ACTIVE COMPARATOR

Administered IV

Drug: Iron sucrose

Interventions

Iron isomaltoside/ferric derisomaltose DRUG

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.

Also known as: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

Iron isomaltoside/ferric derisomaltose

Iron sucrose DRUG

Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes 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.

Also known as: Venofer®

Iron sucrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, ≥ 18 years
• Hb ≤ 11 g/dL
• 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
• Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
• Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
• Willingness to participate and signing the informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (141)

Pharmacosmos Investigational Site

Huntsville, Alabama, 35805, United States

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Pharmacosmos Investigational Site

Little Rock, Arkansas, 72204, United States

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Pharmacosmos Investigational Site

Little Rock, Arkansas, 72205, United States

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Chula Vista, California, 91910, United States

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Fresno, California, 93720, United States

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Glendale, California, 91204, United States

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Glendale, California, 91206, United States

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Granada Hills, California, 91344, United States

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La Mesa, California, 91942, United States

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Pharmacosmos Investigational Site

Los Angeles, California, 90022, United States

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Pharmacosmos Investigational Site

Los Angeles, California, 90025, United States

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Pharmacosmos Investigational Site1

Los Angeles, California, 90048, United States

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Pharmacosmos Investigational Site2

Los Angeles, California, 90048, United States

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Pharmacosmos Investigational Site

Los Angeles, California, 90057, United States

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Pharmacosmos Investigational Site

Lynwood, California, 90262, United States

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Montebello, California, 90640, United States

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Northridge, California, 31324, United States

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Northridge, California, 91324, United States

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Porterville, California, 93257, United States

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Rialto, California, 92377, United States

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Riverside, California, 92505, United States

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Sacramento, California, 95825, United States

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San Dimas, California, 91773, United States

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San Francisco, California, 94110, United States

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Tarzana, California, 91356, United States

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Arvada, Colorado, 80002, United States

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Denver, Colorado, 80218, United States

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Westminster, Colorado, 80031, United States

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Middlebury, Connecticut, 06762, United States

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Plainville, Connecticut, 06062, United States

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Boynton Beach, Florida, 33426, United States

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Brandon, Florida, 33511, United States

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Coral Gables, Florida, 33134, United States

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Coral Springs, Florida, 33071, United States

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Doral, Florida, 33166, United States

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Fort Lauderdale, Florida, 33308, United States

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Pharmacosmos Investigational Site1

Hialeah, Florida, 33012, United States

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Pharmacosmos Investigational Site2

Hialeah, Florida, 33012, United States

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Pharmacosmos Investigational Site3

Hialeah, Florida, 33012, United States

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Pharmacosmos Investigational Site

Hollywood, Florida, 33024, United States

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Pharmacosmos Investigational Site

Homestead, Florida, 33030, United States

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Pharmacosmos Investigational Site

Lake City, Florida, 32024, United States

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Pharmacosmos Investigational Site1

Lauderdale Lakes, Florida, 33313, United States

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Pharmacosmos Investigational Site2

Lauderdale Lakes, Florida, 33313, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33015, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33015, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33133, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33135, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site3

Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33145, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33145, United States

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Pharmacosmos Investigational Site3

Miami, Florida, 33145, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33147, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33165, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33165, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33172, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33173, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33175, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33175, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33176, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33183, United States

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Pharmacosmos Investigational Site1

Miami, Florida, 33186, United States

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Pharmacosmos Investigational Site2

Miami, Florida, 33186, United States

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Pharmacosmos Investigational Site

Miami Beach, Florida, 33140, United States

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Miami Lakes, Florida, 33014, United States

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Pharmacosmos Investigational Site

Naples, Florida, 34102, United States

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Ocala, Florida, 34471, United States

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Palmetto Bay, Florida, 33157, United States

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Pembroke Pines, Florida, 33026, United States

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Plantation, Florida, 33322, United States

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Pharmacosmos Investigational Site

Port Charlotte, Florida, 33952, United States

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Pharmacosmos Investigational Site

St. Petersburg, Florida, 33713, United States

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Pharmacosmos Investigational Site1

Tampa, Florida, 33607, United States

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Pharmacosmos Investigational Site2

Tampa, Florida, 33607, United States

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Pharmacosmos Investigational Site

Tampa, Florida, 33614, United States

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Pharmacosmos Investigational Site

West Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site

Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30901, United States

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Pharmacosmos Investigational Site

Macon, Georgia, 31217, United States

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Pharmacosmos Investigational Site

Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60643, United States

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Crystal Lake, Illinois, 60012, United States

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Hinsdale, Illinois, 60521, United States

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Fort Wayne, Indiana, 48604, United States

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Marion, Indiana, 46952, United States

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Merrillville, Indiana, 46410, United States

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Michigan City, Indiana, 46360, United States

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Kansas City, Kansas, 66160, United States

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Wichita, Kansas, 67214, United States

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Owensboro, Kentucky, 42301, United States

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Baton Rouge, Louisiana, 70808, United States

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Covington, Louisiana, 70433, United States

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Shreveport, Louisiana, 71101, United States

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Annapolis, Maryland, 21401, United States

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Bethesda, Maryland, 20817, United States

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Rockville, Maryland, 20852, United States

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Pharmacosmos Investigational Site

Grand Rapids, Michigan, 49525, United States

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Florissant, Missouri, 63031, United States

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Albuquerque, New Mexico, 87109, United States

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Flushing, New York, 11355, United States

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Pharmacosmos Investigational Site

New York, New York, 10010, United States

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Pharmacosmos Investigational Site

New York, New York, 10016, United States

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Asheville, North Carolina, 28801, United States

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Gastonia, North Carolina, 28054, United States

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Greenville, North Carolina, 27834, United States

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Jacksonville, North Carolina, 28546, United States

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Wilmington, North Carolina, 28401, United States

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Pharmacosmos Investigational Site

Cincinnati, Ohio, 45206, United States

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Pharmacosmos Investigational Site

Cincinnati, Ohio, 45220, United States

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Cleveland, Ohio, 44106, United States

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Pharmacosmos Investigational Site

Norman, Oklahoma, 73069, United States

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Tulsa, Oklahoma, 74136, United States

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Pharmacosmos Investigational Site

Bethlehem, Pennsylvania, 18107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Columbia, South Carolina, 29203, United States

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Greenville, South Carolina, 29605, United States

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Orangeburg, South Carolina, 29118, United States

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Jackson, Tennessee, 38305, United States

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Austin, Texas, 78758, United States

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Beaumont, Texas, 77702, United States

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Pharmacosmos Investigational Site

DeSoto, Texas, 75115, United States

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Pharmacosmos Investigational Site

El Paso, Texas, 79935, United States

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Pharmacosmos Investigational Site

Fort Worth, Texas, 76104, United States

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Pharmacosmos Investigational Site

Greenville, Texas, 75401, United States

Location

Pharmacosmos Investigational Site1

Houston, Texas, 77030, United States

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Pharmacosmos Investigational Site2

Houston, Texas, 77030, United States

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Pharmacosmos Investigational Site

Houston, Texas, 77084, United States

Location

Pharmacosmos Investigational Site

Houston, Texas, 77089, United States

Location

Pharmacosmos Investigational Site1

Houston, Texas, 77099, United States

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Pharmacosmos Investigational Site2

Houston, Texas, 77099, United States

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Pharmacosmos Investigational Site

Lufkin, Texas, 75904, United States

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Pharmacosmos Investigational Site

McKinney, Texas, 75069, United States

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Pharmacosmos Investigational Site

Pearland, Texas, 77581, United States

Location

Pharmacosmos Investigational Site1

San Antonio, Texas, 78215, United States

Location

Pharmacosmos Investigational Site2

San Antonio, Texas, 78215, United States

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Pharmacosmos Investigational Site

St. George, Utah, 84790, United States

Location

Pharmacosmos Investigational Site

Arlington, Virginia, 22207, United States

Location

Pharmacosmos Investigational Site

Fairfax, Virginia, 22033, United States

Location

Related Publications (2)

• Sunil Bhandari, Lars Lykke Thomsen. Single 1000 mg infusion of iron isomaltoside1000 single 1000 mg infusion of iron isomaltoside 1000 demonstrates a more rapid hemoglobin response and reduced risk of cardiovascular adverse events compared to multiple dose iron sucrose In patients with iron deficiency anemia and nondialysis-dependent CKD. Nephrology Dialysis Transplantation 34 (Supplement 1): i349-i350, 2019, https://academic.oup.com/ndt/article/34/Supplement_1/gfz101.SaO035/5515662

  RESULT

• Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.

  PMID: 32049331 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

iron isomaltoside 1000; ferric derisomaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Clinical trial disclosure desk
• Organization: Pharmacosmos A/S

trial@pharmacosmos.com

+45 5948 5935

Study Officials

• Pharmacosmos A/S Clinical and Non-clinical Research

  Pharmacosmos A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 21, 2016
• Study Start: November 29, 2016
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: October 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (141)