An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

NCT02962648 | Completed Phase 3 Results DMC

• 1 other identifier: P-Monofer-IDA/CKD-EXT-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 22

Brief Summary

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Conditions

Iron Deficiency Anemia; Iron Deficiency Anaemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Drug Reactions (ADR)

  Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.

  Baseline to week 26

Secondary Outcomes (8)

• Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

  Baseline to week 26

• Composite Cardiovascular Adverse Events (AEs)

  Baseline to week 26

• Time to First Composite Cardiovascular Safety AE

  Baseline, week 2, 13, and 26

• S-phosphate <2 mg/dL at Any Time From Baseline to Week 26

  Baseline to week 26

• Change in Hb From Baseline to Week 2, 13, and 26

  Baseline, week 2, 13, and 26

Study Arms (1)

Iron isomaltoside/ferric derisomaltose

EXPERIMENTAL

Administered IV

Drug: Iron isomaltoside/ferric derisomaltose

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 from the site's supply and administered over approximately 20 minutes using IV infusion.

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

Iron isomaltoside/ferric derisomaltose

Eligibility Criteria

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

You may qualify if:

• Completed one of the lead-in trials
• Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
• Haemoglobin (Hb) of ≤ 11 g/dL
• Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
• Willingness to participate and signing the informed consent form (ICF)

You may not qualify if:

• Intravenous (IV) iron treatment between the lead-in trial and screening
• During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
• Received an investigational drug within 30 days of screening
• Decompensated liver cirrhosis or active hepatitis
• Pregnant or nursing women.
• Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (22)

Pharmacosmos Investigational Site

Chula Vista, California, 91910, United States

Location

Pharmacosmos Investigational Site 1

La Mesa, California, 91942, United States

Location

Pharmacosmos Investigational Site 2

La Mesa, California, 91942, United States

Location

Pharmacosmos Investigational Site

Northridge, California, 91324, United States

Location

Pharmacosmos Investigational Site

Porterville, California, 93257, United States

Location

Pharmacosmos Investigational Site

Doral, Florida, 33172, United States

Location

Pharmacosmos Investigational Site

Hialeah, Florida, 33012, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33135, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33147, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33165, United States

Location

Pharmacosmos Investigational Site

Miami Lakes, Florida, 33014, United States

Location

Pharmacosmos Investigational Site

West Palm Beach, Florida, 33409, United States

Location

Pharmacosmos Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Pharmacosmos Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pharmacosmos Investigational Site

New Orleans, Louisiana, 70125, United States

Location

Pharmacosmos Investigational Site

Shreveport, Louisiana, 71101, United States

Location

Pharmacosmos Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Pharmacosmos Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Pharmacosmos Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

Pharmacosmos Investigational Site

Houston, Texas, 77030, United States

Location

Pharmacosmos Investigational Site 1

San Antonio, Texas, 78215, United States

Location

Pharmacosmos Investigational Site 2

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

iron isomaltoside 1000; ferric derisomaltose

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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: January 9, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: March 10, 2020
• Results First Posted: March 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)