AnemiaPhase 2NCT00924781

A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)

A Phase 2 study testing MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline and MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline 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 evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Anemia, Chronic Kidney Disease
What is being tested?: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline and MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: No sites listed yet
Study dates: Jun 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Base Study:
Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
Patient has been on hemodialysis for at least 6 months when informed consent is signed
Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed
Extension Study:
Patient completed the base study through Week 12
Patient tolerated MK2578 and demonstrated compliance with study procedures

Who cannot join

Patient has a life expectancy of less than 6 months
Patient is scheduled for 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 12 weeks of screening or plans to have surgery
Patient has Human Immunodeficiency Virus (HIV)
Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia

Show all 9Show fewer

Patient has severe congestive heart failure (CHF)
Patient has a history of malignant cancer, except certain skin or cervical cancers
Patient has a history of grand mal seizures within the last 6 months

About this study

Official title: A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis.

Read the detailed description

This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Conditions: Anemia, Chronic Kidney Disease
Being tested: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
Keywords: Anemia associated with chronic kidney disease (CKD), Hemodialysis
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.

MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at BaselineDrug
MK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort.
MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at BaselineDrug
MK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.
MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at BaselineDrug
MK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.

Study groups in NCT00924781
Study group	Role	What they receive
MK2578 1 mcg for every 600 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment every week (QW). Receives: Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline
1 mcg of MK2578 for every 600 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment QM. Receives: Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline
MK2578 1 mcg for every 350 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment QW. Receives: Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline
1 mcg of MK2578 for every 350 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment QM. Receives: Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline
MK2578 1 mcg for every 200 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment QW. Receives: Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
1 mcg of MK2578 for every 200 U of Epogen at Baseline	Experimental	Participants were randomized to receive treatment QM. Receives: Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline

What is being measured

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

Change From Baseline in Hemoglobin (Hg) Level at Week 4
Measured: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
Measured: 12 weeks
Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
Measured: 12 weeks
Number of Participants With Composite Events of Infusion Reactions
Measured: 12 weeks
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Measured: 12 weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
Measured: 12 weeks

Secondary outcomes (1)

Change From Baseline in Hg Level at Week 12
Measured: 12 weeks

Timeline

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

Jun 2009May 2010

First posted19 Jun 2009 (estimated)
Study startJun 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.
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: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00924781
Sponsor's protocol ID: 2578-003
Other IDs: 2009_603
Status last verified: Oct 2015
First submitted: 18 Jun 2009
Last updated: 2 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Anemia trials

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 II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis.
ClinicalTrials.gov ID: NCT00924781
Acronym / sponsor ID: 2578-003
Conditions: Anemia, Chronic Kidney Disease
Keywords: Anemia associated with chronic kidney disease (CKD), Hemodialysis
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 39 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 19 Jun 2009 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
MK2578 1 mcg for every 600 U of Epogen at Baseline	Experimental	Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment every week (QW).
1 mcg of MK2578 for every 600 U of Epogen at Baseline	Experimental	Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment QM.
MK2578 1 mcg for every 350 U of Epogen at Baseline	Experimental	Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment QW.
1 mcg of MK2578 for every 350 U of Epogen at Baseline	Experimental	Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment QM.
MK2578 1 mcg for every 200 U of Epogen at Baseline	Experimental	Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment QW.
1 mcg of MK2578 for every 200 U of Epogen at Baseline	Experimental	Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at BaselineParticipants were randomized to receive treatment QM.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
Patient has been on hemodialysis for at least 6 months when informed consent is signed
Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed
Patient completed the base study through Week 12
Patient tolerated MK2578 and demonstrated compliance with study procedures

Key exclusion criteria (9 listed)

Patient has a life expectancy of less than 6 months
Patient is scheduled for 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 12 weeks of screening or plans to have surgery
Patient has Human Immunodeficiency Virus (HIV)

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
MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at BaselineMK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort.	Drug	1 mcg of MK2578 for every 600 U of Epogen at Baseline, MK2578 1 mcg for every 600 U of Epogen at Baseline
MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at BaselineMK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.	Drug	1 mcg of MK2578 for every 350 U of Epogen at Baseline, MK2578 1 mcg for every 350 U of Epogen at Baseline
MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at BaselineMK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.	Drug	1 mcg of MK2578 for every 200 U of Epogen at Baseline, MK2578 1 mcg for every 200 U of Epogen at Baseline

Primary outcome

Change From Baseline in Hemoglobin (Hg) Level at Week 4
Time frame: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
Time frame: 12 weeks
Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
Time frame: 12 weeks
Number of Participants With Composite Events of Infusion Reactions
Time frame: 12 weeks
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Time frame: 12 weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
Time frame: 12 weeks

1 secondary outcome

Change From Baseline in Hg Level at Week 12
Time frame: 12 weeks

Results and safety

Results posted to the registry on 29 Mar 2012, 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 1mcg/600 U or 1 mcg/350 U QW	20	8
MK2578 1mcg/600 U or 1 mg/350 U QM	19	9

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

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

Measure	MK2578 1mcg/600U QW n = 16	MK2578 1mcg/600U QM n = 14	MK2578 1mcg/350U QW n = 1	MK2578 1mcg/350U QM n = 1
Value	-0.6 (0.8)	-0.7 (1.0)	-1.0 (NA)	-1.0 (NA)

Population analysed: Full analysis set

Primary outcome: Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

Time frame: 12 weeks. Number. Unit: Participants

Measure	MK2578 1mcg/600U QW n = 16	MK2578 1mcg/600U QM n = 15	MK2578 1mcg/350U QW n = 4	MK2578 1mcg/350U QM n = 4
Value	0	1	0	0

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

Time frame: 12 weeks. Number. Unit: Participants

Measure	MK2578 1mcg/600U QW n = 16	MK2578 1mcg/600U QM n = 15	MK2578 1mcg/350U QW n = 4	MK2578 1mcg/350U QM n = 4
Value	0	0	0	0

Primary outcome: Number of Participants With Composite Events of Infusion Reactions

Time frame: 12 weeks. Number. Unit: Participants

Measure	MK2578 1mcg/600U QW n = 16	MK2578 1mcg/600 QM n = 15	MK2578 1mcg/350U QW n = 4	MK2578 1mcg/350U QM n = 4
Value	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK2578 QW	1 of 20 (5%)	9 of 20 (45%)	Not reported
MK2578 QM	2 of 19 (10.5%)	7 of 19 (36.8%)	Not reported

Limitations and caveats (from the sponsor): Cohort 3 (MK2578 1mcg/200U) was not initiated because the study was prematurely terminated by the sponsor. All randomized participants received at least one dose of study medication. Data presented are for Cohort 1 and Cohort 2, where applicable.

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.

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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?

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 7 inclusion and 9 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 29 Mar 2012). 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 (Hg) 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 NCT00924781.

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.