Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2010/091/000417
CTRI/2010/091/000417CompletedPhase 3

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. - Nil

Pharmacosmos AS0 sites350 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
350
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •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).

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 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. History of immunodeficiency, including positive HIV test result.
  • •20. Body weight < 30 kilograms

Investigators

Sponsor
Pharmacosmos AS

Similar Trials

Recruiting
Phase 3
To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is equivalent to IV iron sucrose determined as ability to maintain the iron level to certain limits in patients already on iron therapy with CKD-5D who are on maintenance iron therapy
CTRI/2011/05/001740Lars Christensen MD351
Active, not recruiting
Not Applicable
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.
EUCTR2009-016728-29-DEPharmacosmos A/S350
Active, not recruiting
Not Applicable
A study to compare Iron Isomaltoside 1000 (Monofer®), as single or repeated injections, with intravenous Iron Sucrose in subjects with Chronic Kidney Disease and who is on Dialysis Therapy (CKD-5D) and have reached stage 5 in their disease.Stage 5 Chronic Kidney DiseaseMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
EUCTR2010-023471-26-SEPharmacosmos A/S351
Active, not recruiting
Not Applicable
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison with Intravenous Iron Sucrose in Subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).Stage 5 Chronic Kidney Disease on Dialysis Threapy (CKD-5D)MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857
EUCTR2010-023471-26-PLPharmacosmos A/S350
Active, not recruiting
Not Applicable
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.
EUCTR2010-023471-26-DKPharmacosmos A/S350