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Clinical Trials/EUCTR2007-002380-27-CZ
EUCTR2007-002380-27-CZActive, not recruitingNot Applicable

A single arm open label study to assess the efficacy, safety and tolerability and of once-monthly administration of intravenous C.E.R.A. for the maintanance of haemoglobin levels in dialysis patients with chronic renal anaemia. - STABI

Roche s.r.o.0 sites200 target enrollmentStarted: July 3, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Written informed consent
  • •2. Age 18 years and older
  • •3. Chronic renal anaemia
  • •4. Haemoglobin concentration between 10.5g/dl and 12.5g/dl
  • •5. Adequite iron status (serum ferritin > 100ng/ml AND TSAT > 20% OR hypochromic red cells < 10%)
  • •6. Continuous intracenous maintenence epoetin (epoetin alfy, epoetin beta or darbopoetin alfa) therapy with the same dosing interval during the previous two months
  • •7. Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months
  • •8. Kt/V > 1.0 at screening for haemodialysis patients (or URR > 55%)
  • •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

  • •1. Transfusion of red blood cells during the previous 2 months
  • •2. Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of epoetin (epoetin alfa, epoetin beta or darbopoetin alfa) treatment in the previous 6 months
  • •3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding
  • •4. Active malignant disease (except non-melanoma skin cancer)
  • •5. Haemolysis
  • •6. Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
  • •7. Folic acid deficiency
  • •8. Vitamin B12 deficiency
  • •9. Platelet count > 500 x10 9/l or < 100x 10 9/l
  • •10. Pure red cell aplasia
  • •11. Epileptic seizure during previous 6 months
  • •12. Congestive heart failure (NYHA Class IV)
  • •13. Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
  • •14. Uncontrolled or symptomatic secondary hyperparathyroidism
  • •15. Pregnancy or lactation period
  • •16. Women of childbearing potential without effective contraception
  • •17. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
  • •18. Known hypersensitivity to recobinant human erathropoietin, polyethylene glycol or to any constituent of the study medication
  • •19. Planned (date) elective surgery during the study period except for
  • •- cataract surgery
  • •- temporary (untunneled) dialysis access catheter

Investigators

Sponsor
Roche s.r.o.

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