Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD5D) MedDRA version: 15.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Iron isomaltoside 1000
CAS Number: 9004-66-4
Concentration unit: mg milligram(s)
Con
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be included if they meet all of the following criteria: 1. Men or women, aged 18 years or greater. 2. Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days. 3. Life expectancy beyond 12 months by Principal Investigator’s judgement. 4. Willingness and ability to participate after Informed Consent. 5. Hb concentrations between 9.5 g/dL and 12.5 g/dL (both values included) both at Screening Visit 1a and at Screening Visit 1b (screening Visit 1a and Visit 1b must be separated by at least 1 week). 6. Serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Anaemia caused primarily by factors other than renal related anaemia. 2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 3. Patients currently undergoing treatment with immunosuppresives (low dose steroids are allowed during the study conduct for dosages no more than 10 mg prednisolone/day or equivalent. If possible the dosage should be kept constant through the study). 4. Difference of Hb = 1.0 g/dL between screening (Visits 1a and 1b). 5. Patients with a history of multiple allergies. 6. Decompensated liver cirrhosis [Alanine Aminotransferase (ALT) > 3 times normal] or history of Hepatitis B or C. 7. Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood Cells (WBC) and C - reactive protein (CRP). 8. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 9. Pregnancy or 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: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches] 10. Blood transfusion within the previous 12 weeks. 11. Planned elective surgery in the next 8 weeks. 12. Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives prior to screening. 13. Untreated Vitamin B12 or folate deficiency. 14. 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. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is noninferior to IV iron sucrose determined as ability to maintain Hb in subjects with CKD5D who are on maintenance iron therapy.;Secondary Objective: The secondary objectives are: • To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) for the maintenance of Haemoglobin in subjects with CKD-5D who are on maintenance iron therapy • To evaluate the safety of intravenous iron isomaltoside 1000 (Monofer®) in comparison with iron sucrose administered intravenously in patients with CKD-5D • To compare iron related hematological parameters (haemoglobin (Hb), Transferrin Saturation (TfS), serum iron, serum ferritin levels and reticulocyte count) • To evaluate the number of subjects who discontinue study due to lack of response or intolerance • Assess changes in Quality of Life (QoL) by Linear Analog Scale Assessment (LASA) • Assess Restless Legs Syndrome (RLS) symptoms and change in these symptoms during the study.;Primary end point(s): The primary endpoint of the study is: 1. Proportion of patients able to maintain haemoglobin between 9.5 and 12.5 g/dl (both values included) at week 6.;Timepoint(s) of evaluation of this end point: week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points of the study are: 1. Change in Hb concentration from baseline to week 2, 4, and 6. 2. Safety laboratory assessments at baseline and 1, 2, 4 and 6 weeks. 3. Change in concentrations of serum iron, TfS, serum ferritin and reticulocyte count from baseline to week 1, 2, 4 and 6. 4. Number of subjects in each randomization group who discontinue study because of lack of response or intolerance of investigational drugs. 5. Change in total QoL score (LASA) from baseline to week 4 and 6. 6. Change in RLS symptoms (CH-RLSq score) from baseline to week 6 in subjects with RLS symptoms at baseline. 7. Number of subjects who experience any Adverse Drug Reaction (ADR) including any Suspected Unexpected Serious Adverse Reaction (SUSAR).;Timepoint(s) of evaluation of this end point: 1. from baseline to week 2, 4 and 6. 2. from baseline and 1, 2, 4 and 6 weeks. 3. from baseline to week 1, 2, 4 and 6. 5. from baseline to week 4 and 6. 6. from baseline to week 6 | — |
Countries
Denmark, India, Poland, Romania, Russian Federation, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical R&D
Pharmacosmos A/S
Outcome results
None listed