Trial | NCT00563446  Report issue

Title

Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
Conversion From Once Weekly Recombinant Human Erythropoietin to Once Monthly Darbepoetin Alfa for the Treatment of Renal Anemia in Continuous Ambulatory Peritoneal Dialysis Patients

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows dosing at extended intervals and less frequent injection.

The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an extended once monthly dosing interval in the treatment of renal anaemia in continuous ambulatory peritoneal dialysis.
Study Started
Jul 31
2005
Study Completion
May 31
2006
Last Update
Jun 16
2011
Estimate

Drug Darbepoetin alfa

Criteria 

Inclusion Criteria:

Patients on continuous ambulatory peritoneal dialysis
Patients receiving subcutaneous recombinant human erythropoietin (rHuEPO)
Patients with haemoglobin level ?10 g/dL and remain stable for the past 3 months while receiving rHuEPO

Exclusion Criteria:

Uncontrolled hypertension
Severe congestive heart failure (NYHA class III or IV)
Grand mal epilepsy
Any kind of blood loss causing Fe depletion
Presence of infection, either acute or chronic, or inflammatory conditions within 3 months preceding the study
Malignancy
Aluminum toxicity
Severe hyperparathyroidism with marrow fibrosis or osteitis fibrosa _ PTH > 20 times of normal
Vitamin B12 or folate deficiency _ MCV > 100fL
Haemolysis
Marrow dysfunction e.g. aplastic anaemia, myelodysplastic syndrome, multiple myeloma, etc
Thalassaemia major, intermediate or minor, or red cell enzyme defects
Blood transfusion within 3 months preceding the study
Pregnancy or lactating mothers
No Results Posted