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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_603 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK2578 1 mcg for every 600 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment every week (QW). |
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| 1 mcg of MK2578 for every 600 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment QM. |
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| MK2578 1 mcg for every 350 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment QW. |
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| 1 mcg of MK2578 for every 350 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment QM. |
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| MK2578 1 mcg for every 200 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment QW. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin (Hg) Level at Week 4 | 4 weeks | |
| Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | 12 weeks | |
| Number of Participants With Composite Events of Transfusion-Related Adverse Experiences | 12 weeks | |
| Number of Participants With Composite Events of Infusion Reactions | 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 | 12 weeks | |
| Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hg Level at Week 12 | 12 weeks |
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Inclusion Criteria:
Base Study:
Extension Study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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At randomization, participants received either MK2578 or matching placebo on Day 1 and crossed over to the alternate treatment at the next dialysis treatment on Day 3.
Participants were recruited from 46 centers (9 centers in Bulgaria, 27 in United States, 3 in Romania, 4 in Italy, and 3 in Poland).
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| ID | Title | Description |
|---|---|---|
| FG000 | MK2578 1mcg/600 U or 1 mcg/350 U QW | MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline. |
| FG001 | MK2578 1mcg/600 U or 1 mg/350 U QM |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 mcg of MK2578 for every 200 U of Epogen at Baseline | Experimental | Participants were randomized to receive treatment QM. |
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| MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline | Drug | 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. |
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| MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline | Drug | 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. |
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MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline. |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK2578 1mcg/600U QW | MK2578 IV administered QW. |
| BG001 | MK2578 1mcg/600U QM | MK2578 IV administered QM. |
| BG002 | MK2578 1mcg/350U QW | MK2578 IV administered QW. |
| BG003 | MK2578 1mcg/350U QM | MK2578 IV administered QM. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 (Hg) Level at Week 4 | Full analysis set | Posted | Mean | Standard Deviation | g/dL | 4 weeks |
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| Primary | Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Posted | Number | Participants | 12 weeks |
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| Primary | Number of Participants With Composite Events of Transfusion-Related Adverse Experiences | Posted | Number | Participants | 12 weeks |
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| Primary | Number of Participants With Composite Events of Infusion Reactions | Posted | Number | Participants | 12 weeks |
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| Primary | 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 | Posted | Number | Participants | 12 weeks |
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| Primary | Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 | Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination. | Posted | 12 weeks |
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| Secondary | Change From Baseline in Hg Level at Week 12 | Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed. | Posted | Mean | Standard Deviation | g/dL | 12 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 | MK2578 QW | MK2578 IV administered once weekly. | 1 | 20 | 9 | 20 | ||
| EG001 | MK2578 QM | MK2578 IV administered once every 4 weeks. | 2 | 19 | 7 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute mycoardial infarction | Cardiac disorders | MedDRA 11.1 |
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| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.1 |
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| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 |
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| Tachycardia | Cardiac disorders | MedDRA 11.1 |
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| Adrenal cyst | Endocrine disorders | MedDRA 11.1 |
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| Abdominal distention | Gastrointestinal disorders | MedDRA 11.1 |
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| Gastritis | Gastrointestinal disorders | MedDRA 11.1 |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 11.1 |
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| Asthenia | General disorders | MedDRA 11.1 |
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| Non-cardiac chest pain | General disorders | MedDRA 11.1 |
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| Oedema peripheral | General disorders | MedDRA 11.1 |
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| Bacterial disease carrier | Infections and infestations | MedDRA 11.1 |
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| Bronchitis | Infections and infestations | MedDRA 11.1 |
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| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 |
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| Pneumonia | Infections and infestations | MedDRA 11.1 |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Haemodialysis-induced symptom | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Blood pressure increased | Investigations | MedDRA 11.1 |
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| Haemoglobin decreased | Investigations | MedDRA 11.1 |
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| Ultrasound pelvis abnormal | Investigations | MedDRA 11.1 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Dizziness | Nervous system disorders | MedDRA 11.1 |
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| Headache | Nervous system disorders | MedDRA 11.1 |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 11.1 |
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| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 11.1 |
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| Anxiety | Psychiatric disorders | MedDRA 11.1 |
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| Renal vein thrombosis | Renal and urinary disorders | MedDRA 11.1 |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 11.1 |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Arterial occlusive disease | Vascular disorders | MedDRA 11.1 |
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| Brachiocephalic vein stenosis | Vascular disorders | MedDRA 11.1 |
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| Hypertension | Vascular disorders | MedDRA 11.1 |
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| Hypotension | Vascular disorders | MedDRA 11.1 |
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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.
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.
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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