Anemia in Pre-Dialysis PatientsPhase 3NCT00433615
Clinical Study of R744 to Predialysis Patients
A Phase 3 study testing R744 in people with Anemia in Pre-Dialysis Patients, run by Chugai Pharmaceutical at 6 sites in Japan.
Trial summary
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anemia in Pre-Dialysis Patients
- What is being tested?
- R744
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 6 sitesJapan
- Study dates
- Feb 2007to Nov 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≥ 30 mL /min at any one time point within 12 weeks before registration
- Patients aged ≥ 20 years at the time of obtaining consent
- Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
- Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and <13.0 g/dL
- Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration
Who cannot join
- Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions within 12 weeks before registration)
- Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
- Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure in the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
- Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
- Patients who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been > 12.0 g/dL
- ⅰ)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
Show all 18Show fewer
- ⅱ)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment )
- ⅲ)Patients with congestive cardiac failure (≥ Class II in Fontaine arteriosclerosis obliterans classification)
- Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
- Patients hypersensitive to a rHuEPO preparation
- Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage
- Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
- Patients who have received another investigational drug within 12 weeks before registration
- Patients who have received R744 before registration
- Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
- Patients who have received erythrocyte transfusion within 16 weeks before registration
- Patients for whom a surgical operation accompanied by marked bleeding is planned during the study period
- In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Chubu region
Chūbu
Chugoku/Shikoku region
Chugoku/Shikoku
Hokkaido/Tohoku region
Hokkaido/Tohoku
Kanto/Koshinetsu region
Kanto/Koshinetsu
Kinki/Hokuriku region
Kinki/Hokuriku
Kyusyu region
Kyusyu
About this study
Official title: Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
- Conditions
- Anemia in Pre-Dialysis Patients
- Being tested
- R744
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R744Drug
Also called methoxy polyethylene glycol-epoetin beta
100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
R744Drug
Also called methoxy polyethylene glycol-epoetin beta
150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: R744 |
| 2 | Experimental | Not described Receives: Drug: R744 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Maintenance of target Hb concentration
Measured: 24th and 48th week
Secondary outcomes (7)
Slope of regression line of Hb concentration (g/dL/week)
Measured: 24th week
Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL
Measured: 24th week
Ratio of Maintenance of Hb concentration
Measured: 24th and 48th week
Adverse events
Measured: 24th and 48th week
Laboratory measurements
Measured: 24th and 48th week
Vital signs, standard 12-lead ECG
Measured: 24th and 48th week
Anti-R744 antibody titer
Measured: 24th and 48th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in Pre-Dialysis PatientsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takanori Baba, Study chair, Clinical Research Department 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433615
- Sponsor's protocol ID
- JH20566
- Status last verified
- Jan 2009
- First submitted
- 9 Feb 2007
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).
- ClinicalTrials.gov ID
- NCT00433615
- Acronym / sponsor ID
- JH20566
- Conditions
- Anemia in Pre-Dialysis Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Feb 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.
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: R744 |
| 2 | Experimental | Drug: R744 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≥ 30 mL /min at any one time point within 12 weeks before registration
- Patients aged ≥ 20 years at the time of obtaining consent
- Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
- Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and <13.0 g/dL
- Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration
Key exclusion criteria (18 listed)
- Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions within 12 weeks before registration)
- Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
- Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure in the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
- Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
- Patients who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been > 12.0 g/dL
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 |
|---|---|---|
| R744Also: methoxy polyethylene glycol-epoetin beta100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks | Drug | 1 |
| R744Also: methoxy polyethylene glycol-epoetin beta150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks | Drug | 2 |
Primary outcome
Ratio of Maintenance of target Hb concentration
Time frame: 24th and 48th week
7 secondary outcomes
Slope of regression line of Hb concentration (g/dL/week)
Time frame: 24th week
Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL
Time frame: 24th week
Ratio of Maintenance of Hb concentration
Time frame: 24th and 48th week
Adverse events
Time frame: 24th and 48th week
Laboratory measurements
Time frame: 24th and 48th week
Vital signs, standard 12-lead ECG
Time frame: 24th and 48th week
Anti-R744 antibody titer
Time frame: 24th and 48th week
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 2 Feb 2009.
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.
Takanori Baba study chair
Clinical Research Department 2
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R744 in people with Anemia in Pre-Dialysis Patients, run by Chugai Pharmaceutical at 6 sites 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 5 inclusion and 18 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 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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?
Ratio of Maintenance of target Hb concentration (time frame: 24th and 48th week). 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 2 Feb 2009.