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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, End-stage renal failure, Continuous ambulatory peritoneal dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Hemoglobin level

Secondary Outcome Measures

Full Information

First Posted
November 21, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
Kirin Pharmaceutical (Asia) CO., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT00563446
Brief Title
Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
Official Title
Conversion From Once Weekly Recombinant Human Erythropoietin to Once Monthly Darbepoetin Alfa for the Treatment of Renal Anemia in Continuous Ambulatory Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Kirin Pharmaceutical (Asia) CO., LTD

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory
Keywords
Anemia, End-stage renal failure, Continuous ambulatory peritoneal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Primary Outcome Measure Information:
Title
Hemoglobin level
Time Frame
Over 6 months

10. Eligibility

Sex
All
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel KS Fung, Dr
Organizational Affiliation
Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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