Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

NCT01102413 | Completed Phase 3 Results DMC

• 1 other identifier: P-Monofer-CKD-02
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).

Conditions

Iron Deficiency Anemia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.

  Baseline, 4 weeks

Secondary Outcomes (1)

• Change in Hemoglobin Concentration From Baseline to Week 8

  Baseline to week 8

Study Arms (2)

Monofer

EXPERIMENTAL

Injections or infusions

Drug: Monofer

Iron Sulphate

ACTIVE COMPARATOR

Oral intake

Drug: Iron Sulphate

Interventions

Monofer DRUG

Infusion or injections

Monofer

Iron Sulphate DRUG

Oral intake

Iron Sulphate

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, aged more than 18 years.
• Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
• Hb \< 11.0 g/dL (6.80 mmol/L)
• Either or both of the following iron stores indicators below target {Serum ferritin \< 100 ug/l and Transferrin saturation (TfS)\<20%}.
• Life expectancy beyond 12 months by Principal Investigator's judgement.
• Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information \[PHI\] for North America).

You may not qualify if:

• Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
• Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
• Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
• Subjects with history of multiple allergies.
• Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper normal limit).
• Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
• Rheumatoid arthritis with symptoms or signs of active joint inflammation.
• Pregnancy and 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 (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
• Extensive active bleeding necessitating blood transfusion.
• Planned elective surgery during the study.
• Participation in any other clinical study within 3 months prior to screening.
• Known intolerance to oral iron treatment.
• Untreated B12 or folate deficiency.
• I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
• ESA treatment within 8 weeks prior to screening visit.

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Pharmacosmos

Holbæk, Denmark

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

Iron-Dextran Complex

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)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Vice President Research & Development Department
• Organization: Pharmacosmos A/S

llt@pharmacosmos.com

+45 59485959

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: March 26, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 3, 2015
• Results First Posted: December 3, 2015

Record last verified: 2015-11

Locations

DK (1)