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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563446

Enrollment

Registered

2007-11-26

Start date

2005-07-31

Completion date

2006-05-31

Last updated

2011-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory

Keywords

Anemia, End-stage renal failure, Continuous ambulatory peritoneal dialysis

Brief summary

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.

Interventions

DRUGDarbepoetin alfa

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin level	Over 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026