Trial Outcomes & Findings for A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002) (NCT NCT00968617)

NCT ID: NCT00968617

Last Updated: 2015-11-02

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2015-11-02

Participant Flow

Participants in Cohorts 1 and 2 were to receive 1.0 mcg/kg/month and 2.0 mcg/kg/month, respectively, of MK2578. Participants in Cohort 3 were to be randomized to MK2578 3.6 mcg/kg/month or to weekly doses of darbepoetin alfa 0.45 mcg/kg/week. Cohort 1 was the only cohort initiated.

Participant milestones

Measure	MK2578 MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Overall Study STARTED	7
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	MK2578 MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Overall Study Study terminated by sponsor	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Age, Continuous	60.9 years STANDARD_DEVIATION 5.01 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Change From Baseline in Hemoglobin Level at Week 4 Baseline Hemoglobin	9.3 g/dL Standard Deviation 0.4
Change From Baseline in Hemoglobin Level at Week 4 Change from Baseline in Hemoglobin at Week 4	0.5 g/dL Standard Deviation 0.4

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
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	0 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Number of Participants With Composite Events of Transfusion-related Adverse Experiences	0 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Number of of Participants With Composite Events of Injection Site Reactions	1 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia Hypertension	1 Participants
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia Seizure	0 Participants
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia Pure red cell aplasia	0 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578	NA Participants Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.

SECONDARY outcome

Timeframe: Weeks 1-10 and Week 12

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Hemoglobin Concentration After Treatment With MK2578 Week 1 (n=6)	9.2 g/dL Standard Deviation 0.8
Hemoglobin Concentration After Treatment With MK2578 Week 2 (n=5)	9.8 g/dL Standard Deviation 0.6
Hemoglobin Concentration After Treatment With MK2578 Week 3 (n=5)	9.9 g/dL Standard Deviation 0.7
Hemoglobin Concentration After Treatment With MK2578 Week 4 (n=7)	9.8 g/dL Standard Deviation 0.6
Hemoglobin Concentration After Treatment With MK2578 Week 5 (n=5)	10.3 g/dL Standard Deviation 0.7
Hemoglobin Concentration After Treatment With MK2578 Week 6 (n=4)	10.4 g/dL Standard Deviation 0.8
Hemoglobin Concentration After Treatment With MK2578 Week 7 (n=3)	10.8 g/dL Standard Deviation 0.9
Hemoglobin Concentration After Treatment With MK2578 Week 8 (n=4)	11.1 g/dL Standard Deviation 0.7
Hemoglobin Concentration After Treatment With MK2578 Week 9 (n=2)	10.9 g/dL Standard Deviation 0.4
Hemoglobin Concentration After Treatment With MK2578 Week 10 (n=1)	10.6 g/dL Standard Deviation NA No standard deviation exists for n=1.
Hemoglobin Concentration After Treatment With MK2578 Week 12 (n=1)	11.1 g/dL Standard Deviation NA No standard deviation exists for n=1.

SECONDARY outcome

Timeframe: Weeks 1-3, 5-10, and Week 12

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 5 (n=5)	0.9 g/dL Standard Deviation 0.4
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 6 (n=4)	1.0 g/dL Standard Deviation 0.6
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 1 (n=6)	-0.1 g/dL Standard Deviation 0.6
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 2 (n=5)	0.5 g/dL Standard Deviation 0.4
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 3 (n=5)	0.6 g/dL Standard Deviation 0.7
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 7 (n=3)	1.3 g/dL Standard Deviation 0.7
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 8 (n=4)	1.6 g/dL Standard Deviation 0.4
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 9 (n=2)	1.5 g/dL Standard Deviation 0.1
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 10(n=1)	1.6 g/dL Standard Deviation NA No standard deviation exists for n=1.
Change From Baseline in Hemoglobin Level Change from Baseline in Hemoglobin at Week 12(n=1)	2.1 g/dL Standard Deviation NA No standard deviation exists for n=1.

SECONDARY outcome

Timeframe: Each week up to 12 weeks

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.

Outcome measures

Measure	MK2578 n=7 Participants MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
Number of Participants Who Were Responders	4 Participants

Adverse Events

MK-2578

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MK-2578 n=7 participants at risk
Cardiac disorders Tachycardia	14.3% 1/7 • Number of events 1
Eye disorders Retinal detachment	14.3% 1/7 • Number of events 1
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1
Infections and infestations Urinary tract infection	14.3% 1/7 • Number of events 1
Injury, poisoning and procedural complications Accidental overdose	14.3% 1/7 • Number of events 1
Injury, poisoning and procedural complications Contusion	14.3% 1/7 • Number of events 1
Vascular disorders Hypertension	14.3% 1/7 • Number of events 1

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
• Publication restrictions are in place

Restriction type: OTHER