Kidney Failure, ChronicPhase 3NCT00213291
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
A Phase 3 study testing darbepoetin alfa in people with Kidney Failure, Chronic, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Oct 2005
- Phase
- Phase 3
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis
- clinically stable
- hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin < 110 g/L
- not iron deficient (TSAT > 19.5%) within 4 weeks of study entry
- stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive
- written informed consent from parent/legal guardian
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- less than 18 years old
- weight at least 10 kg
- females of childbearing potential must practice adequate contraception
- availability for follow-up assessments
Who cannot join
- scheduled for a living donor kidney transplant within 12 weeks of signing consent
- uncontrolled blood pressure as judged by principal investigator
- change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment
- current clinical evidence of severe hyperparathyroidism
- major surgery 2 weeks before signing consent
- active inflammatory disease or condition requiring immunosuppressive therapy
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- currently receiving antibiotics for active systemic infection
- peritoneal dialysis patient with an episode of peritonitis within the past 30 days
- known HIV antibody positivity
- known antibodies to rHuEPO
- known aluminum toxicity
- known red cell aplasia
- known malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure
This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.
Read the detailed description
Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of proliferation and differentiation of red blood cell precursors. The main cause of anemia in children with chronic renal failure is deficiency of EPO production as a result of declining renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that is structurally and functionally similar to naturally occuring EPO. Treatment of anemia using rHuEPO has been associated with an improvement in the quality of life for patients, likely attributable to an increased production in hemoglobin and a reduction of dilatation of the heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin alfa, has been described as having a more prolonged effect requiring less frequent dosing.
There are currently no data available on the efficacy of darbepoetin alfa administered every 14-28 days for children. The most common dosing schedules in the clinical trial at HSC are every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection, and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10 day dosing schedule for the administration of Darbepoetin.
- Conditions
- Kidney Failure, Chronic
- Being tested
- darbepoetin alfa
- Keywords
- chronic kidney failure, darbepoetin, pediatrics, anemia
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaDrug
Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of darbepoetin when administered at an increased dosing interval
Measured: 40 weeks
Secondary outcomes (4)
Safety and tolerability of darbepoetin
Measured: 40 weeks
Proportion of subjects who receive red blood cell transfusions
Measured: 40 weeks
Percentage of Hb data points that exceed upper target of 125 g/L
Measured: 16-36 weeks
Incidence of anti-erythropoietin antibody formation
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Geary, The Hospital for Sick Children
- Investigators
- Denis F Geary, MD, Principal investigator, The Hospital For Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213291
- Sponsor's protocol ID
- 1000004731
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2005
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00213291
- Acronym / sponsor ID
- 1000004731
- Conditions
- Kidney Failure, Chronic
- Keywords
- chronic kidney failure, darbepoetin, pediatrics, anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Oct 2005
- First posted
- 21 Sep 2005 (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.
This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.
Detailed description
Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of proliferation and differentiation of red blood cell precursors. The main cause of anemia in children with chronic renal failure is deficiency of EPO production as a result of declining renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that is structurally and functionally similar to naturally occuring EPO. Treatment of anemia using rHuEPO has been associated with an improvement in the quality of life for patients, likely attributable to an increased production in hemoglobin and a reduction of dilatation of the heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin alfa, has been described as having a more prolonged effect requiring less frequent dosing.
There are currently no data available on the efficacy of darbepoetin alfa administered every 14-28 days for children. The most common dosing schedules in the clinical trial at HSC are every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection, and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10 day dosing schedule for the administration of Darbepoetin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: darbepoetin alfa |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis
- clinically stable
- hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin < 110 g/L
- not iron deficient (TSAT > 19.5%) within 4 weeks of study entry
- stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive
Key exclusion criteria (13 listed)
- scheduled for a living donor kidney transplant within 12 weeks of signing consent
- uncontrolled blood pressure as judged by principal investigator
- change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment
- current clinical evidence of severe hyperparathyroidism
- major surgery 2 weeks before signing consent
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 alfaDarbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study. | Drug | 1 |
Primary outcome
The safety of darbepoetin when administered at an increased dosing interval
Time frame: 40 weeks
4 secondary outcomes
Safety and tolerability of darbepoetin
Time frame: 40 weeks
Proportion of subjects who receive red blood cell transfusions
Time frame: 40 weeks
Percentage of Hb data points that exceed upper target of 125 g/L
Time frame: 16-36 weeks
Incidence of anti-erythropoietin antibody formation
Time frame: 40 weeks
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 26 Aug 2013.
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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.
Denis F Geary, MD principal investigator
The Hospital For Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darbepoetin alfa in people with Kidney Failure, Chronic, run by The Hospital for Sick Children at 1 site in Canada.
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 10 inclusion and 13 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 26 Aug 2013. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The safety of darbepoetin when administered at an increased dosing interval (time frame: 40 weeks). 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 26 Aug 2013.