MDSPhase 2NCT01497145
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
A Phase 2 study testing KRN321 in people with MDS, run by Kyowa Kirin Co., Ltd. at 2 sites in 2 countries.
Trial summary
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- MDS
- What is being tested?
- KRN321
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2011to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
- Serum EPO concentration ≤ 500 mIU/mL
- Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations
Who cannot join
- Previous bone marrow or hematopoietic stem cell transplantation
- History of pure red cell aplasia
- Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
- Those who have increased risk of thrombosis during the study
- Uncontrolled diabetes mellitus
- Concurrent active infection or chronic inflammatory disease
- Other causes of anemia
- Previous or concurrent active malignancies other than MDS
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndrome
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.
- Conditions
- MDS
- Being tested
- KRN321
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRN321Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497145
- Sponsor's protocol ID
- KRN321-401
- Status last verified
- Mar 2015
- First submitted
- 20 Dec 2011
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01497145
- Acronym / sponsor ID
- KRN321-401
- Conditions
- MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Dec 2011 (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 multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
- Serum EPO concentration ≤ 500 mIU/mL
- Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations
Key exclusion criteria (8 listed)
- Previous bone marrow or hematopoietic stem cell transplantation
- History of pure red cell aplasia
- Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
- Those who have increased risk of thrombosis during the study
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| KRN321 | Drug | – |
Primary outcome
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety
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 4 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KRN321 in people with MDS, run by Kyowa Kirin Co., Ltd. at 2 sites in 2 countries.
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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, South Korea. 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?
The proportion of subjects achieving a erythroid response. The study lists 2 primary outcomes in all. 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 4 Mar 2015.