HemodialysisPhase 2NCT00744445
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
A Phase 2 study testing r-HuEPO in people with Hemodialysis and Chronic Renal Failure, run by Sunnybrook Health Sciences Centre.
Trial summary
The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Chronic Renal Failure, Anemia
- What is being tested?
- r-HuEPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 1993to Aug 1998
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
- Serum ferritin level > 200 micrograms/L and transferrin saturation > 15%
- Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
- Prior therapy with r-HuEPO
- An adequate program of dialysis established
- Informed consent signed
Who cannot join
- Adocumented cause of anemia other than chronic renal disease
- Symptoms of unstable coronary artery disease
- Poorly controled hypertension
- Known seizure disorder
- Other active inflammatory or infective disorders
- Other disorders that may diminish the response of the bone marrow to r-HuEPO
About this study
The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.
Read the detailed description
This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.
- Conditions
- Hemodialysis, Chronic Renal Failure, Anemia
- Being tested
- r-HuEPO
- Keywords
- hemodialysis, erythropoietin
- 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.
r-HuEPODrug
r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
| Study group | Role | What they receive |
|---|---|---|
| 0800 | Active comparator | r-HuEPO administered at 0800 hrs Receives: Drug: r-HuEPO |
| 1500 | Active comparator | r-HuEPO administered at 1500 hrs Receives: Drug: r-HuEPO |
| 2200 | Active comparator | r-HuEPO administered at 2200 hrs Receives: Drug: r-HuEPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for hematocrit to rise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startOct 1993
- Primary completionAug 1998
- Study completionAug 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Georg Bjarnason, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744445
- Sponsor's protocol ID
- 022-1994
- Status last verified
- Aug 2008
- First submitted
- 29 Aug 2008
- Last updated
- 1 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
- ClinicalTrials.gov ID
- NCT00744445
- Acronym / sponsor ID
- 022-1994
- Conditions
- Hemodialysis, Chronic Renal Failure, Anemia
- Keywords
- hemodialysis, erythropoietin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Oct 1993
- Primary completion
- Aug 1998 (actual)
- Study completion
- Aug 1998 (actual)
- First posted
- 1 Sep 2008 (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.
The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.
Detailed description
This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0800 | Active comparator | Drug: r-HuEPOr-HuEPO administered at 0800 hrs |
| 1500 | Active comparator | Drug: r-HuEPOr-HuEPO administered at 1500 hrs |
| 2200 | Active comparator | Drug: r-HuEPOr-HuEPO administered at 2200 hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
- Serum ferritin level > 200 micrograms/L and transferrin saturation > 15%
- Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
- Prior therapy with r-HuEPO
- An adequate program of dialysis established
Key exclusion criteria (6 listed)
- Adocumented cause of anemia other than chronic renal disease
- Symptoms of unstable coronary artery disease
- Poorly controled hypertension
- Known seizure disorder
- Other active inflammatory or infective disorders
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 |
|---|---|---|
| r-HuEPOr-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites. | Drug | 0800, 1500, 2200 |
Primary outcome
Time for hematocrit to rise
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 1 Sep 2008.
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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.
Georg Bjarnason, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing r-HuEPO in people with Hemodialysis and Chronic Renal Failure, run by Sunnybrook Health Sciences Centre.
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 6 inclusion and 6 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 1 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time for hematocrit to rise. 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 1 Sep 2008.