Anemia, Chronic Kidney Disease, Chronic Renal Failure
Conditions
Keywords
anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemodialysis, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
Brief summary
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.
Detailed description
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure. Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents (ESAs). Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study (NCT00228449) and were to receive doses of peginesatide for approximately 54 months. However, the Sponsor ended the study early.
Interventions
DRUGpeginesatide
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
Sponsors
Affymax
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines * Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. * Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study * One hemoglobin value of \> 10.0 g/dL in the 4 weeks prior to study drug administration
Exclusion criteria
* Known intolerance to peginesatide or pegylated products * History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA) * High likelihood of early withdrawal or interruption of the study (e.g., participant suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant) * Anticipated life expectancy \< 18 months * Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change | Up to 54 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginesatide Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Patient Relocation | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Renal transplant | 6 |
| Overall Study | Sponsor Decision to Terminate Study | 41 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Peginesatide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age Continuous | 59.8 years STANDARD_DEVIATION 15.01 |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 77 / 81 |
| serious Total, serious adverse events | 58 / 81 |
Outcome results
Primary
Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change
Time frame: Up to 54 months
Population: Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginesatide | Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change | 0.867 percentage of participants |