MDSPhase 3NCT01362140
Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
A Phase 3 study testing Darbepoetin alfa in people with MDS, run by Amgen at 72 sites in 9 countries.
Trial summary
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDS
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 72 sitesin 9 countries
- Study dates
- 21 Dec 2011to 14 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Low or intermediate-1 risk MDS patients per International Prognostic Scoring System (IPSS) at the time of randomisation, as determined by complete blood count (CBC) during screening and bone marrow examination and marrow cytogenetic analysis performed within 16 weeks prior to randomisation. Subject cannot have been rendered low or intermediate-1 risk by prior disease modifying therapy. Bone marrow slides must be available for centralized review at any time throughout the study
- World Health Organization (WHO) classification of refractory anemia (RA), refractory anemia with ring sideroblasts (RARS), refractory cytopenias with multilineage dysplasia (RCMD), MDS-unclassified (MDSU), MDS with isolated del(5q) (5q- syndrome) or refractory anaemia with excess blasts-1 (RAEB-1)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 assessed during screening
- Haemoglobin level ≤ 10.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomisation (retest during screening is acceptable)
- Adequate transferrin saturation (Tsat) (≥ 15%) and serum ferritin (≥ 10 ng/mL) as assessed by the central laboratory during screening (supplementation and retest during screening is acceptable)
- Adequate serum folate (≥ 4.5 nmol/L [≥ 2.0 ng/mL]) or RBC folate (≥ 317 nmol/L [≥ 140 ng/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable)
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- Adequate vitamin B12 (≥ 148 pmol/L [≥ 200 pg/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable)
- 18 years of age or older
- Subject or subject's legally acceptable representative has provided informed consent -
Who cannot join
- Previously diagnosed with intermediate-2 or high risk MDS per IPSS
- Therapy-related or secondary MDS
- History of acute leukemia
- Evidence of bone marrow collagen fibrosis
- Inherited anaemia (eg, haemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency), active hemorrhage, red cell aplasia, haemolytic anaemia
- History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma
Show all 32Show fewer
- History of thrombosis within 6 months prior to randomisation
- Previous bone marrow or stem cell transplantation
- Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomisation
- Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening
- Clinically significant systemic infection or uncontrolled chronic inflammatory disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator at screening
- History of seizure disorder (subject with previous history of seizure disorder will be eligible for the study if he/she had no evidence of seizure activity within 5 years of randomisation and is currently free of antiseizure medication)
- Previous or ongoing use of erythropoiesis-stimulating agent (ESA) therapy, eg, recombinant human erythropoietin (rHuEpo), darbepoetin alfa
- High transfusion demand: receiving a total of ≥ 4 units of RBC transfusion during either of 2 consecutive 8-week periods (ie, days -113 to -57 or days -56 to 0) prior to randomisation
- Received any RBC transfusion within 14 days prior to randomisation
- Received cytotoxic chemotherapy for any oncologic indication or planning to receive cytotoxic chemotherapy during the double-blind treatment period of the study
- Received biologic response modifiers (eg, thalidomide, lenalidomide, arsenic trioxide, azacitidine, decitabine) to treat MDS or planning to receive biologic response modifiers during the double-blind treatment period of the study
- Received myeloablative or craniospinal radiation or planning to receive myeloablative or craniospinal radiation during the double-blind treatment period of the study
- Received granulocyte colony stimulating factor (G-CSF) therapy within 30 days prior to randomization or planning to receive G-CSF therapy during the double-blind treatment period of the study (temporary use of G-CSF for neutropenia with fever and/or infection is acceptable)
- Abnormal renal function (serum creatinine level > 2 times the upper limit of the respective normal range [ULN]) as assessed by the central laboratory at screening
- Abnormal liver function (total bilirubin > 2 times, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times ULN) as assessed by the central laboratory at screening. (Subjects with abnormal bilirubin at screening due to documented Gilbert's Disease are eligible if all other criteria are met.)
- Serum endogenous erythropoetin (EPO) level > 500 mU/mL as assessed by the central laboratory at screening
- Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of acquired Immunodeficiency syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
- Subjects with active ethanol abuse, as judged by the investigator
- Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- Female subject is not willing to use highly effective contraception during treatment and for at least 1 month after the end of treatment
- Female subject is pregnant or planning to become pregnant within 1 month after the end of treatment
- Subject has known sensitivity to any of the products to be administered during dosing
- Subject has previously been randomised into this study
- Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
- Confirmed history of neutralising antibody activity to rHuEpo or darbepoetin alfa
Trial locations and contacts
72 sites in 9 countries.
72 sites in 9 countries
Italy13 sites
Research Site
Alessandria, 15100
Research Site
Bologna, 40138
Research Site
Genova, 16132
Research Site
Milan, 20122
Research Site
Palermo, 90146
Research Site
Pavia, 27100
Research Site
Pesaro, 61100
Research Site
Pisa, 56127
Research Site
Reggio Calabria, 89124
Research Site
Rionero in Vulture PZ, 85028
Research Site
Roma, 00161
Research Site
San Giovanni Rotondo FG, 71013
Research Site
Udine, 33100
France12 sites
Research Site
Avignon, 84902
Research Site
Bobigny, 93009
Research Site
Caen, 14033
Research Site
Lyon, 69009
Research Site
Lyon Cédex 3, 69437
Research Site
Nantes, 44035
Research Site
Nice, 06202
Research Site
Paris, 75015
Research Site
Paris, 75475
Research Site
Pontoise, 95301
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511
Belgium11 sites
Research Site
Bruges, 8000
Research Site
Brussels, 1200
Research Site
Charleroi, 6000
Research Site
Ghent, 9000
Research Site
Haine Saint Paul - La Louviere, 7100
Research Site
Hasselt, 3500
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Ottignies, 1340
Research Site
Roeselare, 8800
Research Site
Sint-Niklaas, 9100
Czechia9 sites
Research Site
Brno, 625 00
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Ostrava-Poruba, 708 52
Research Site
Prague, 100 34
Research Site
Prague, 128 08
Research Site
Prague, 128 20
Research Site
Prague, 150 06
Research Site
Zlín, 760 01
Germany9 sites
Research Site
Cologne, 50677
Research Site
Dresden, 01307
Research Site
Göttingen, 37075
Research Site
Hanover, 30625
Research Site
Leipzig, 04103
Research Site
Mannheim, 68167
Research Site
Regensburg, 93053
Research Site
Rotenburg (Wümme), 27356
Research Site
Ulm, 89081
Greece5 sites
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Ioannina, 45110
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 57010
Spain5 sites
Research Site
Barcelona, Catalonia, 08003
Research Site
Salamanca, Castille and León, 37007
Research Site
Valencia, Valencia, 46010
Research Site
Valencia, Valencia, 46026
Research Site
Zaragoza, Aragon, 50009
Austria4 sites
Research Site
Innsbruck, 6020
Research Site
Linz, 4020
Research Site
Salzburg, 5020
Research Site
Vienna, 1140
Switzerland4 sites
Research Site
Basel, 4031
Research Site
Lucerne, 6000
Research Site
Muensterlingen, 8596
Research Site
Zurich, 8091
About this study
Official title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.
Read the detailed description
This study consists of a 3-week screening period, a 24-week double-blind treatment period, and a 48-week active treatment period and the long-term follow-up period.
An end of treatment period (EOTP) visit occurs at week 25, or 3 weeks after last dose of investigational product (IP) for participants who withdraw from the study. After entering the active treatment period, an end of active treatment period (EOATP) visit occurs at week 72 / 73, or 3 weeks after the last dose of darbepoetin alfa.
Long-term follow-up (LTFU) will occur every 26 weeks (± 4 weeks) from the EOATP visit (or EOTP visit if the participant does not enter the active treatment period) and will continue for a minimum of 3 years from the first dose of IP. Follow-up may occur through clinic visit or telephone contacts. Information on the participant's survival and progression to AML status will be collected during LTFU.
- Conditions
- MDS
- Being tested
- Darbepoetin alfa, Placebo
- Keywords
- Randomized, Darbepoetin alfa, Myelodysplastic Syndromes, Placebo-controlled, low risk MDS, intermediate-1 risk MDS, International Prognostic Scoring System
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Aranesp
Administered by subcutaneous injection every 3 weeks
PlaceboDrug
Administered by subcutaneous injection every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Experimental | Participants received darbepoetin alfa 500 µg every three weeks (Q3W) for 24 weeks in the double-blind treatment period, and continued to receive darbepoetin alfa 500 µg Q3W during the active treatment period for an additional 48 weeks. Receives: Drug: Darbepoetin alfa |
| Placebo | Placebo comparator | Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks during the double-blind treatment period. From week 25 participants received darbepoetin alfa 500 µg Q3W during the active treatment period for 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period
Measured: Week 5 to Week 25
Secondary outcomes (8)
Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period
International Working Group 2006 erythroid response was defined as achieving an initial ≥ 1.5 g/dL increase in hemoglobin from baseline and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56-consecutive day period in the absence of RBC transfusion.
Participants with no hemoglobin collected to the minimum time required to observe an IWG erythroid response (Week 13) were considered non-responders.
Measured: Up to 24 weeks
Number of Participants With Adverse Events
The severity of each adverse event was graded using the the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.
Prespecified adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer, included the following categories: hypersensitivity, cardiac failure, hypertension, malignancies, embolic and thrombolic events, venous thromboembolic events (VTEs), central nervous system vascular disorders, and ischemic heart disease.
Measured: From first dose of study drug until the end of the double-blind treatment period; 24 weeks.
Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)
Transformation to AML was assessed according to WHO guidelines in the absence of IP and any haematopoietic growth factors (2 weeks off dosing). Bone marrow and/or cytogenetic report confirmation of AML was required (marrow or peripheral blast cells ≥ 20%, presence of pathognomic AML cytogenetic change, or evidence of marrow blast criteria for erythroleukemia). A pathology report confirming other leukemias such as chloroma (granulocytic sarcoma, myeloid sarcoma) or leukemia cutis also constituted transformation to AML.
Measured: 24 weeks
Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin
Measured: Up to 24 weeks
Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
Two validated assays were used to detect the presence of anti-darbepoetin alfa antibodies.
Samples were first tested in an immunoassay to detect antibodies capable of binding to darbepoetin alfa. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against darbepoetin alfa. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
The number of participants who developed antibodies to darbepoetin alfa is defined as participants who were neutralizing antibody positive post-baseline with a negative or no result at baseline.
Measured: Baseline and end of double-blind treatment period (24 weeks)
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement. End of treatment period (EOTP) analysis includes last available values.
Measured: Baseline, and weeks 13 and 25
Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D visual analog scale (VAS) is a global evaluation of overall health state with scores ranging from 0 (worse health state a participant can imagine) to 100 (best health state a participant can imagine).
End of treatment period (EOTP) analysis includes last available values.
Measured: Baseline, and weeks 13 and 25
Percentage of Participants With a Clinically Meaningful Improvement in Fatigue
The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
Clinically meaningful improvement in fatigue is defined as an increase of ≥ 3 points in the FACIT-Fatigue subscale score, from baseline to EOTP.
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study start21 Dec 2011
- Primary completion11 Feb 2015
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MDSStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362140
- Sponsor's protocol ID
- 20090160
- Other IDs
- 2009-016522-14, 2009
- Status last verified
- Nov 2017
- First submitted
- 26 May 2011
- Last updated
- 19 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, Slama B, Badre S, Gasal E, Mehta B, Franklin J. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017 Sep;31(9):1944-1950. doi: 10.1038/leu.2017.192. Epub 2017 Jun 19.
PubMed 28626220
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01362140
- Acronym / sponsor ID
- 20090160
- Conditions
- MDS
- Keywords
- Randomized, Darbepoetin alfa, Myelodysplastic Syndromes, Placebo-controlled, low risk MDS, intermediate-1 risk MDS, International Prognostic Scoring System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2011 (actual)
- Primary completion
- 11 Feb 2015 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.
Detailed description
This study consists of a 3-week screening period, a 24-week double-blind treatment period, and a 48-week active treatment period and the long-term follow-up period.
An end of treatment period (EOTP) visit occurs at week 25, or 3 weeks after last dose of investigational product (IP) for participants who withdraw from the study. After entering the active treatment period, an end of active treatment period (EOATP) visit occurs at week 72 / 73, or 3 weeks after the last dose of darbepoetin alfa.
Long-term follow-up (LTFU) will occur every 26 weeks (± 4 weeks) from the EOATP visit (or EOTP visit if the participant does not enter the active treatment period) and will continue for a minimum of 3 years from the first dose of IP. Follow-up may occur through clinic visit or telephone contacts. Information on the participant's survival and progression to AML status will be collected during LTFU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | Experimental | Drug: Darbepoetin alfaParticipants received darbepoetin alfa 500 µg every three weeks (Q3W) for 24 weeks in the double-blind treatment period, and continued to receive darbepoetin alfa 500 µg Q3W during the active treatment period for an additional 48 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks during the double-blind treatment period. From week 25 participants received darbepoetin alfa 500 µg Q3W during the active treatment period for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Low or intermediate-1 risk MDS patients per International Prognostic Scoring System (IPSS) at the time of randomisation, as determined by complete blood count (CBC) during screening and bone marrow examination and marrow cytogenetic analysis performed within 16 weeks prior to randomisation. Subject cannot have been rendered low or intermediate-1 risk by prior disease modifying therapy. Bone marrow slides must be available for centralized review at any time throughout the study
- World Health Organization (WHO) classification of refractory anemia (RA), refractory anemia with ring sideroblasts (RARS), refractory cytopenias with multilineage dysplasia (RCMD), MDS-unclassified (MDSU), MDS with isolated del(5q) (5q- syndrome) or refractory anaemia with excess blasts-1 (RAEB-1)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 assessed during screening
- Haemoglobin level ≤ 10.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomisation (retest during screening is acceptable)
- Adequate transferrin saturation (Tsat) (≥ 15%) and serum ferritin (≥ 10 ng/mL) as assessed by the central laboratory during screening (supplementation and retest during screening is acceptable)
Key exclusion criteria (32 listed)
- Previously diagnosed with intermediate-2 or high risk MDS per IPSS
- Therapy-related or secondary MDS
- History of acute leukemia
- Evidence of bone marrow collagen fibrosis
- Inherited anaemia (eg, haemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency), active hemorrhage, red cell aplasia, haemolytic anaemia
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 alfaAlso: AranespAdministered by subcutaneous injection every 3 weeks | Drug | Darbepoetin alfa |
| PlaceboAdministered by subcutaneous injection every 3 weeks | Drug | Placebo |
Primary outcome
Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period
Time frame: Week 5 to Week 25
8 secondary outcomes
Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period
Time frame: Up to 24 weeks
Number of Participants With Adverse Events
Time frame: From first dose of study drug until the end of the double-blind treatment period; 24 weeks.
Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)
Time frame: 24 weeks
Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin
Time frame: Up to 24 weeks
Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
Time frame: Baseline and end of double-blind treatment period (24 weeks)
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline, and weeks 13 and 25
Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)
Time frame: Baseline, and weeks 13 and 25
Percentage of Participants With a Clinically Meaningful Improvement in Fatigue
Time frame: Baseline to week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28626220Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, Slama B, Badre S, Gasal E, Mehta B, Franklin J. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017 Sep;31(9):1944-1950. doi: 10.1038/leu.2017.192. Epub 2017 Jun 19.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
72 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin alfa in people with MDS, run by Amgen at 72 sites in 9 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 9 inclusion and 32 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in Italy, France, Belgium, Czechia, Germany and 4 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period (time frame: Week 5 to Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362140, which also lists 1 linked publication.
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 19 Dec 2017.