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

Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102413
• Other study ID #: P-Monofer-CKD-02
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2010
• Last updated: November 2, 2015
• Start date: April 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeSweden: Medical Products AgencyIndia: Central Drugs Standard Control OrganizationIndia: Institutional Review BoardSweden: Regional Ethical Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUS: FOOD AND DRUG ADMINISTRATION (FDA) and WESTERN INSTITUTIONAL REVIEW BOARD (WIRB)Poland:Department for Clinical Trials of Medicinal Products Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and Ethics Committee at the Regional Medical Chamber in WarsawRussia: Ministry of Health of the Russian FederationRomania: National Agency for Drug and Medical Devices and National Ethics Committee for Drug Clinical TrialAustria: BASG/AGES and Ethikkommission des Landes OberösterreichGermany: Ethikkommission der Ärztekammer Niedersachsen and BfArMIreland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women, aged more than 18 years.

2. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.

3. Hb < 11.0 g/dL (6.80 mmol/L)

4. Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.

5. Life expectancy beyond 12 months by Principal Investigator's judgement.

6. Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).

Exclusion Criteria:

1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).

2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).

3. 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.

4. Subjects with history of multiple allergies.

5. Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).

6. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).

7. Rheumatoid arthritis with symptoms or signs of active joint inflammation.

8. 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).

9. Extensive active bleeding necessitating blood transfusion.

10. Planned elective surgery during the study.

11. Participation in any other clinical study within 3 months prior to screening.

12. Known intolerance to oral iron treatment.

13. Untreated B12 or folate deficiency.

14. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.

15. ESA treatment within 8 weeks prior to screening visit.

16. Serum ferritin > 500 µg/L.

17. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.

18. Body weight < 30 kilograms.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Chronic Kidney Disease
• Iron Deficiency Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Monofer
Infusion or injections
• Iron Sulphate
Oral intake

Locations

Country	Name	City	State
Denmark	Pharmacosmos	Holbaek

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.		Baseline, 4 weeks	No
Secondary	Change in Hemoglobin Concentration From Baseline to Week 8		Baseline to week 8	No