Et randomiseret, komparativt, ikke-blindt fase III-forsøg med intravenøst jernisomaltosid 1000 (Monofer®), indgivet som vedligeholdelsesbehandling med enkelte eller gentagne bolusinjektioner sammenlignet med intravenøst jernsukrose hos forsøgspersoner med kronisk nyresygdom i stadie 5, som er i dialyse.

• Conditions: Stage 5 Chronic Kidney Disease on Dialysis Threapy (CKD5D); MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-023471-26-DK
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-18
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

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

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 10.0 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 < 800 ng/mL.
7. Transferrin Saturation < 35%.
8. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to inclusion
(with only 1 missed dose to be allowed. Does to be kept stable during the study period).
9. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4
weeks (with only 1 missed dose to be allowed. Does to be kept stable during the study
period).
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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 or active hepatitis [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.

Study & Design

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