Correction of anemia in ESA-naïve patients with chronic kidney disease (CKD) who are not on dialysis.
Conditions
Interventions
Product Name: MK-2578 PEGylated Erythropoietin
Pharmaceutical Form: Solution for injection
Other descriptive name: MK-2578 PEGylated human erythropoietin
Concentration unit: µg/ml microgram(s)/millili
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a male or female = 18 and = 65 years of age who weighs between 40 and 90 kg at screening Visit 1. 2. Patient is unlikely to conceive, as indicated by at least one es answer to the following questions: a) Patient is a male. b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female = 45 years of age with > 2 years since last menses. d) Patient is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception. Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. 3. Patient must meet the diagnostic criteria for chronic kidney disease as indicated by an estimated glomerular filtration rate (eGFR) between 15-60 mL/min/1.73 m2. Note: Glomerular filtration rate is estimated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 6.10). 4. Patient must meet all laboratory criteria defined in Table 2-1 (See Appendix 6.1 and Appendix 6.2 for an algorithm for assessing pre-study laboratory values and a listing of all laboratory tests performed). Note: For patients whose serum ferritin and transferrin saturation values are below the lower limit of the inclusion ranges, iron supplementation may be started, per center practice. If iron supplementation is initiated at screening, all screening procedures should be delayed, including collection of Hb values used for baseline determination. Screening procedures should subsequently be performed at least one week after the iron dose has been stabilized over 4 weeks, per center practice. If oral iron is not sufficient to correct iron deficiency, intravenous iron may be given. 5. Patient understands the study procedures, alternative treatments available and risks involved with the study, and the patient voluntarily agrees to participate in the study by giving written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is mentally or legally incapacitated, or has significant emotional problems or has a history of psychiatric disorders at the time of screening Visit 1. 2. Patient has used another ESA within 12 weeks of screening Visit 1. 3. Patient is likely to require dialysis during the study and/or is planning to have a kidney transplant within the next 6 months. Note: Patient may be registered for a cadaveric transplant. 4. Patient has had a blood transfusion within 12 weeks of screening Visit 1 for any reason. 5. Patient has had major surgery within the past 12 weeks or plans to have major surgery during the course of the study. Note: Creation of a vascular access and oral surgical procedures are not considered major surgery. 6. Patient has poorly controlled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg at screening Visit 1. 7. Patient has been on androgen therapy within 8 weeks of screening Visit 1. 8. Patient has been diagnosed with the human immunodeficiency virus. 9. Patient has a new or unexplained clinically significant abnormality on pre-study electrocardiogram. 10. Patient has a history of blood dyscrasia, hematologic disorders (including, but not limited to thalassemia, hemoglobinopathy, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, hemolytic anemia, megaloblastic anemia, thrombocytosis, iron deficiency, liver disease) or any other disease known to cause anemia (except for CKD). 11. Patient has Class III or IV (New York Heart Association criteria) congestive heart failure, i.e., with symptoms that occur at rest or with minimal activity (see Appendix 6.3). 12. Patient has a prolonged QTc > 480 ms on pre-study ECG. 13. Patient has a history of a malignant neoplasm, except for adequately treated nonmelanomatous skin lesions or carcinoma in situ of the cervix. 14. Patient has unstable angina or has had a thrombotic vascular event, including but not limited to myocardial infarction (MI), cerebrovascular accident (stroke, CVA), transient ischemic attack (TIA), pulmonary embolus or deep vein thrombosis (DVT) within 6 months of randomization. 15. Patient has a history of grand mal seizures within 6 months of randomization. 16. Patient has an active systemic infection or inflammatory disease or other conditions associated with resistance to ESAs. 17. Patient has a history of antibodies to any ESA, a history of pure red cell aplasia (PRCA) or previous unresponsiveness to ESA. 18. Patient has a known intolerance and/or hypersensitivity to epoetin, darbepoetin alfa, and/or PEGylated products. 19. Patient has participated in a clinical study with an investigational agent within 6 weeks prior to screening Visit 1. 20. Patient is pregnant, has a positive serum pregnancy test during the screening period (prior to randomization), is expecting to conceive within the projected duration of the study or is breastfeeding. 21. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance which in the opinion of the investigator, SPONSOR or its delegates, might pose a risk to the patient or make participation not in the patient’s best interest, that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To define the effective starting dose(s) for subcutaneous administration of MK-2578 to anemic patients with CKD who are not on dialysis and who are ESA naive. 2) To assess the safety and tolerability of subcutaneous administration of MK-2578 in patients with CKD who are not on dialysis. ;Secondary Objective: 1) To determine the percentage of responders over 12 weeks (as defined by patients achieving [pre-transfusion] an increase from baseline Hb of = 1 g/dL and a Hb concentration of = 11 g/dL), the percentage of patients with at least 1 change from baseline Hb of = 1 g/dL (pre-transfusion) over 12 weeks, and the percentage of patients with at least 1 Hb value of = 11 g/dL (pre-transfusion) over 12 weeks. 2) To evaluate the performance of each dose over 12 weeks, as measured by change from baseline Hb by week; the percentage of patients requiring dose decreases; the percentage of patients whose Hb at Week 12 is > 10 g/dL and = 12 g/dL; and the percentage of patients receiving transfusions.;Primary end point(s): Change from baseline Hb at Week 4. | — |
Countries
Bulgaria
Outcome results
None listed