AnemiaPhase 1NCT01083888
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
A Phase 1 study testing roxadustat in people with Anemia and Hemodialysis, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Anemia, Hemodialysis, Renal Impairment
- What is being tested?
- roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 15 Feb 2010to 7 Jun 2010
- Phase
- Phase 1
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic renal failure patients receiving hemodialysis thrice weekly
- Body weight: >=40.0 and <80.0 kg
- Mean hemoglobin level >=10.0 and =<12.0 g/dL
Who cannot join
- Patients with severe inflammation or infection
- Patients who have a medical history of gastrointestinal surgery or enterectomy
- Patients who have uncontrolled hypertension
- Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
- Patients who have a medical history of severe cardiac or cerebrovascular diseases
- Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks
- Patients with a medical history of serious drug allergies
- Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
- Conditions
- Anemia, Hemodialysis, Renal Impairment
- Being tested
- roxadustat
- Keywords
- FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
- Medical subject headings
- Anemia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roxadustatDrug
Also called ASP1517
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 group | Experimental | Participants received a single oral dose of ASP1517 on Days 1 and 8 Receives: Drug: roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASP1517 concentrations in plasma
Measured: For 96 hours after dosing
Secondary outcomes (3)
ASP1517 concentrations in dialysate
Measured: For 6 hours after dosing
Plasma EPO level
Measured: Pre dosing and for 24 hours after dosing
Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests
Measured: For 96 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study start15 Feb 2010
- Primary completion7 Jun 2010
- Study completion7 Jun 2010
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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083888
- Sponsor's protocol ID
- 1517-CL-0203
- Status last verified
- Oct 2024
- First submitted
- 8 Mar 2010
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT01083888
- Acronym / sponsor ID
- 1517-CL-0203
- Conditions
- Anemia, Hemodialysis, Renal Impairment
- Keywords
- FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2010 (actual)
- Primary completion
- 7 Jun 2010 (actual)
- Study completion
- 7 Jun 2010 (actual)
- First posted
- 10 Mar 2010 (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.
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group | Experimental | Drug: roxadustatParticipants received a single oral dose of ASP1517 on Days 1 and 8 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic renal failure patients receiving hemodialysis thrice weekly
- Body weight: >=40.0 and <80.0 kg
- Mean hemoglobin level >=10.0 and =<12.0 g/dL
Key exclusion criteria (8 listed)
- Patients with severe inflammation or infection
- Patients who have a medical history of gastrointestinal surgery or enterectomy
- Patients who have uncontrolled hypertension
- Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
- Patients who have a medical history of severe cardiac or cerebrovascular diseases
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 |
|---|---|---|
| roxadustatAlso: ASP1517oral | Drug | 1 group |
Primary outcome
ASP1517 concentrations in plasma
Time frame: For 96 hours after dosing
3 secondary outcomes
ASP1517 concentrations in dialysate
Time frame: For 6 hours after dosing
Plasma EPO level
Time frame: Pre dosing and for 24 hours after dosing
Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests
Time frame: For 96 hours after dosing
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 30 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study chair
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing roxadustat in people with Anemia and Hemodialysis, run by Astellas Pharma Inc at 1 site in Japan.
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 8 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 30 Oct 2024. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ASP1517 concentrations in plasma (time frame: For 96 hours after dosing). 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 30 Oct 2024.