AnemiaNCT00563446
Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
A study testing Darbepoetin alfa in people with Anemia and Kidney Failure, Chronic, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory
- What is being tested?
- Darbepoetin alfa
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Jul 2005to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Darbepoetin alfa
- Keywords
- Anemia, End-stage renal failure, Continuous ambulatory peritoneal dialysis
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJul 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Kirin Pharmaceutical (Asia) CO., LTD
- Investigators
- Samuel KS Fung, Dr, Principal investigator, Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563446
- Sponsor's protocol ID
- KWC/EX/05-041
- Other IDs
- HARECCTR0500029
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00563446
- Acronym / sponsor ID
- KWC/EX/05-041
- Keywords
- Anemia, End-stage renal failure, Continuous ambulatory peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Kirin Pharmaceutical (Asia) CO., LTD
- Study start
- Jul 2005
- Study completion
- May 2006 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin alfa | Drug | – |
Primary outcome
Hemoglobin level
Time frame: Over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel KS Fung, Dr principal investigator
Division of Nephrology, Medicine & Geriatrics, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Darbepoetin alfa in people with Anemia and Kidney Failure, Chronic, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: Over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.