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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_653 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK2578 1.0 mcg/kg | Experimental | MK2578 |
|
| MK2578 2.0 mcg/kg | Experimental | MK2578 |
|
| MK2578 3.6 mcg/kg | Experimental | MK2578 |
|
| Darbepoetin alfa | Active Comparator | darbepoetin alfa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK2578 | Drug | MK2578 1.0 mcg/kg/month |
| |
| MK2578 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin Level at Week 4 | 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 | 16 Weeks | |
| Number of Participants With Composite Events of Transfusion-related Adverse Experiences | 16 Weeks | |
| Number of of Participants With Composite Events of Injection Site Reactions | 16 Weeks | |
| Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia | 16 Weeks | |
| Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration After Treatment With MK2578 | Weeks 1-10 and Week 12 | |
| Change From Baseline in Hemoglobin Level | Weeks 1-3, 5-10, and Week 12 | |
| Number of Participants Who Were Responders |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK2578 | MK2578 1.0 mcg/kg given subcutaneously (SC) every month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK2578 | MK2578 1.0 mcg/kg given subcutaneously (SC) every month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin Level at Week 4 | Posted | Mean | Standard Deviation | g/dL | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-2578 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| Drug |
MK2578 2.0 mcg/kg/month |
|
| MK2578 | Drug | MK2578 3.6 mcg/kg/month |
|
| Comparator: darbepoetin alfa | Drug | darbepoetin alfa |
|
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. |
| Each week up to 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | 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 | Posted | Number | Participants | 16 Weeks |
|
|
|
| Primary | Number of Participants With Composite Events of Transfusion-related Adverse Experiences | Posted | Number | Participants | 16 Weeks |
|
|
|
| Primary | Number of of Participants With Composite Events of Injection Site Reactions | Posted | Number | Participants | 16 Weeks |
|
|
|
| Primary | Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia | Posted | Number | Participants | 16 Weeks |
|
|
|
| Primary | Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 | Posted | Number | Participants | 16 Weeks |
|
|
|
| Secondary | Hemoglobin Concentration After Treatment With MK2578 | Posted | Mean | Standard Deviation | g/dL | Weeks 1-10 and Week 12 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin Level | Posted | Mean | Standard Deviation | g/dL | Weeks 1-3, 5-10, and Week 12 |
|
|
|
| Secondary | 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. | Posted | Number | Participants | Each week up to 12 weeks |
|
|
|
| 0 |
| 7 |
| 4 |
| 7 |
| Retinal detachment | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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.
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |