A Phase III study where Iron Isomaltoside 1000 (Monofer®) administered by infusions or repeated bolus injections is compared with Iron Sulphate taken by mouth in subjects with non-dialysis dependent chronic kidney disease and with renal-related anaemia.

• Conditions: on-dialysis dependent chronic kidney disease and with renal-related anaemia (NDD-CKD); MedDRA version: 14.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-016728-29-SE
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Subjects with a diagnosis of Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) associated
with renal-related anaemia will be included if they meet all of the following 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 < 200 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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 and hepatitis (alanine aminotransferase (ALT) > 3 times upper
normal limit).
6. Diagnosis of Hepatitis B and/or C confirmed by appropriate lab test.
7. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood
Cells (WBC) and C - Reactive protein (CRP)).
8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
9. 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).
10. Extensive active bleeding necessitating blood transfusion.
11. Planned elective surgery during the study.
12. Participation in any other clinical study within 3 months prior to screening.
13. Known intolerance to oral iron treatment.
14. Untreated B12 or folate deficiency.
15. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
16. ESA treatment within 8 weeks prior to screening visit.
17. Serum ferritin > 500 µg/L.
18. 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.
19. Body weight < 30 kilograms.
20. History of immunodeficiency, including positive HIV test result.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that intravenous Iron Isomaltoside 1000 (Monofer®) is non-inferior to oral iron sulphate in<br>reducing Renal-Related Anaemia in NDD-CKD subjects, determined as ability to increase haemoglobin (Hb).;Secondary Objective: 1. To assess other relevant haematology and biochemical parameters during the study.<br>2. Quality of Life (QoL) assessment by Linear Analog Scale Assessment (LASA).<br>3. To assess safety of intravenous iron isomaltoside 1000 (Monofer®) compared to oral iron sulfate<br>4. Assessment of RLS symptoms and change in these symptoms during the study;Primary end point(s): The primary endpoint of the study is change in Hb concentration from baseline to week 8.;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of subjects who have change in Hb concentration > 1.0 g/dL from baseline to week 2,4 and 8.<br>Number of subjects who have Hb > 11g/dl (6.80 mmol/L), have serum ferritin (200-800 µg/L) and have achieved Transferrin saturation (Tfs) (20-50%) at weeks 2, 4 and 8.