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CompletedNCT00563446Updated Jun 16, 2011

Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia

An interventional study of Darbepoetin alfa in Anemia, Kidney Failure, Chronic and Peritoneal Dialysis, Continuous Ambulatory, sponsored by Hospital Authority, Hong Kong. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2011-06-16.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Anemia
  • End-stage renal failure
  • Continuous ambulatory peritoneal dialysis
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 16 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 73 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Interventions

  • DrugDarbepoetin alfa
06

What researchers measure

Primary outcomes

  1. Hemoglobin level

    Time frame: Over 6 months

07

Study locations

1 site
  • Princess Margaret Hospital
    Hong Kong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00563446
Lead sponsor
Hospital Authority, Hong Kong
Collaborators
Kirin Pharmaceutical (Asia) CO., LTD
First posted
Nov 26, 2007
Start date
Jul 2005
Completion
May 2006
Last update
Jun 16, 2011

Study contacts

Samuel KS Fung, Dr
principal investigator · Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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