AnemiaPhase 2NCT00359840
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
A Phase 2 study testing darbepoetin alfa in people with Anemia, run by Kyowa Kirin Co., Ltd. at 8 sites in Japan.
Trial summary
To assess the clinical effective dose of KRN321 administered with once triweekly schedule. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Anemia
- What is being tested?
- darbepoetin alfa
- How many people
- 120 participants
- Where
- 8 sitesJapan
- Study dates
- Jul 2006to Sep 2007
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed as solid tumor or malignant lymphoma
- patients receiving cyclic chemotherapy
- written informed consent
- hemoglobin concentration below 11 d/dL at enrollment
- life expectancy of more than 4 months
Who cannot join
- hemolysis, gastrointestinal bleeding, postoperative bleeding
- iron deficiency
- megaloblastic anemia
- received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- any primary hematological disorder that could cause anemia
- prior treatment with KRN321
- received erythropoetin therapy within 8 weeks before treatment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Tokai region
Aichi
Shikoku region
Ehime
Kyusyu region
Fukuoka, Kumamoto
Hokkaido region
Hokkaido
Kinki region
Kyoto, Osaka, Nara
Tohoku region
Miyagi
Hokuriku region
Niigata, Ishikawa
Kanto region
Tochigi, Saitama, Tokyo, Kanagawa
About this study
Official title: A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
- Conditions
- Anemia
- Being tested
- darbepoetin alfa
- Keywords
- darbepoetin alfa, anemia, cancer patients, chemotherapy
- Medical subject headings
- Anemia
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.
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary outcomes (3)
To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
To compare the proportion of subjects who receive red blood cell transfusions
To compare the effectiveness of KRN321 based on quality of life scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
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.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nagahiro Saijo, MD, Study chair, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359840
- Sponsor's protocol ID
- KRN321-SC/05-A55
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2006
- Last updated
- 31 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
- ClinicalTrials.gov ID
- NCT00359840
- Acronym / sponsor ID
- KRN321-SC/05-A55
- Conditions
- Anemia
- Keywords
- darbepoetin alfa, anemia, cancer patients, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 3 Aug 2006 (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 clinical effective dose of KRN321 administered with once triweekly schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients diagnosed as solid tumor or malignant lymphoma
- patients receiving cyclic chemotherapy
- written informed consent
- hemoglobin concentration below 11 d/dL at enrollment
- life expectancy of more than 4 months
Key exclusion criteria (7 listed)
- hemolysis, gastrointestinal bleeding, postoperative bleeding
- iron deficiency
- megaloblastic anemia
- received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- any primary hematological disorder that could cause anemia
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
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
3 secondary outcomes
To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
To compare the proportion of subjects who receive red blood cell transfusions
To compare the effectiveness of KRN321 based on quality of life scores
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 31 Aug 2012.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Nagahiro Saijo, MD study chair
National Cancer Center Hospital East
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing darbepoetin alfa in people with Anemia, run by Kyowa Kirin Co., Ltd. at 8 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 7 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response. 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 31 Aug 2012.