AnemiaPhase 2NCT00968617

A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

A Phase 2 study testing MK2578 and Comparator: darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Anemia, Chronic Kidney Disease
What is being tested?: MK2578 and Comparator: darbepoetin alfa
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: No sites listed yet
Study dates: Nov 2009to May 2010
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
Patient has chronic kidney disease

Who cannot join

Patient is morbidly obese
Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
Patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months
Patient has had a blood transfusion within 12 weeks of screening
Patient has had major surgery within the past 12 weeks or plans to have surgery
Patient has Human Immunodeficiency Virus (HIV)

Show all 11Show fewer

Patient has a history of diseases other than CKD known to cause anemia
Patient has severe congestive heart failure
Patient has history of malignant cancer, except certain skin or cervical cancers
Patient has a history of grand mal seizures within the last 6 months
Patient is pregnant or breastfeeding

About this study

Official title: A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Conditions: Anemia, Chronic Kidney Disease
Being tested: MK2578, Comparator: darbepoetin alfa
Keywords: Anemia
Medical subject headings: Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK2578Drug
MK2578 1.0 mcg/kg/month
MK2578Drug
MK2578 2.0 mcg/kg/month
MK2578Drug
MK2578 3.6 mcg/kg/month
Comparator: darbepoetin alfaDrug
darbepoetin alfa

Study groups in NCT00968617
Study group	Role	What they receive
MK2578 1.0 mcg/kg	Experimental	MK2578 Receives: Drug: MK2578
MK2578 2.0 mcg/kg	Experimental	MK2578 Receives: Drug: MK2578
MK2578 3.6 mcg/kg	Experimental	MK2578 Receives: Drug: MK2578
Darbepoetin alfa	Active comparator	darbepoetin alfa Receives: Drug: Comparator: darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin Level at Week 4
Measured: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events
Measured: 16 Weeks
Number of Participants With Composite Events of Transfusion-related Adverse Experiences
Measured: 16 Weeks
Number of of Participants With Composite Events of Injection Site Reactions
Measured: 16 Weeks
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
Measured: 16 Weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
Measured: 16 Weeks

Secondary outcomes (3)

Hemoglobin Concentration After Treatment With MK2578
Measured: Weeks 1-10 and Week 12
Change From Baseline in Hemoglobin Level
Measured: Weeks 1-3, 5-10, and Week 12
Number of Participants Who Were Responders
Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.
Measured: Each week up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2010

First posted31 Aug 2009 (estimated)
Study startNov 2009
Primary completionApr 2010
Study completionMay 2010

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 AnemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00968617
Sponsor's protocol ID: 2578-002
Other IDs: 2009_653
Status last verified: Oct 2015
First submitted: 27 Aug 2009
Last updated: 2 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.
ClinicalTrials.gov ID: NCT00968617
Acronym / sponsor ID: 2578-002
Conditions: Anemia, Chronic Kidney Disease
Keywords: Anemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 7 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 31 Aug 2009 (estimated)
Results: Posted 11 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
MK2578 1.0 mcg/kg	Experimental	Drug: MK2578MK2578
MK2578 2.0 mcg/kg	Experimental	Drug: MK2578MK2578
MK2578 3.6 mcg/kg	Experimental	Drug: MK2578MK2578
Darbepoetin alfa	Active comparator	Drug: Comparator: darbepoetin alfadarbepoetin alfa

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
Patient has chronic kidney disease

Key exclusion criteria (11 listed)

Patient is morbidly obese
Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
Patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months
Patient has had a blood transfusion within 12 weeks of screening
Patient has had major surgery within the past 12 weeks or plans to have surgery

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
MK2578MK2578 1.0 mcg/kg/month	Drug	MK2578 1.0 mcg/kg
MK2578MK2578 2.0 mcg/kg/month	Drug	MK2578 2.0 mcg/kg
MK2578MK2578 3.6 mcg/kg/month	Drug	MK2578 3.6 mcg/kg
Comparator: darbepoetin alfadarbepoetin alfa	Drug	Darbepoetin alfa

Primary outcome

Change From Baseline in Hemoglobin Level at Week 4
Time frame: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events
Time frame: 16 Weeks
Number of Participants With Composite Events of Transfusion-related Adverse Experiences
Time frame: 16 Weeks
Number of of Participants With Composite Events of Injection Site Reactions
Time frame: 16 Weeks
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
Time frame: 16 Weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
Time frame: 16 Weeks

3 secondary outcomes

Hemoglobin Concentration After Treatment With MK2578
Time frame: Weeks 1-10 and Week 12
Change From Baseline in Hemoglobin Level
Time frame: Weeks 1-3, 5-10, and Week 12
Number of Participants Who Were Responders
Time frame: Each week up to 12 weeks

Results and safety

Results posted to the registry on 11 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK2578	7	1

Primary outcome: Change From Baseline in Hemoglobin Level at Week 4

Time frame: 4 weeks. Mean (Standard Deviation). Unit: g/dL

Measure	MK2578 n = 7
Baseline Hemoglobin	9.3 (0.4)
Change from Baseline in Hemoglobin at Week 4	0.5 (0.4)

Primary outcome: Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events

Time frame: 16 Weeks. Number. Unit: Participants

Measure	MK2578 n = 7
Value	0

Primary outcome: Number of Participants With Composite Events of Transfusion-related Adverse Experiences

Time frame: 16 Weeks. Number. Unit: Participants

Measure	MK2578 n = 7
Value	0

Primary outcome: Number of of Participants With Composite Events of Injection Site Reactions

Time frame: 16 Weeks. Number. Unit: Participants

Measure	MK2578 n = 7
Value	1

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-2578	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

Limitations and caveats (from the sponsor): Cohort 1 (MK2578 1.0 mcg/kg) was the only cohort initiated because the study was prematurely terminated by the sponsor. 7 participants received at least 1 dose of MK2578 \& 2 participants received all 3 doses. Data presented are for Cohort 1.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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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
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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK2578 and Comparator: darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Merck Sharp & Dohme LLC.

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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 11 Nov 2011). 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?

Change From Baseline in Hemoglobin Level at Week 4 (time frame: 4 weeks). The study lists 6 primary outcomes in all. 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 NCT00968617, 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 2 Nov 2015.