The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment.
This was a Phase 2, dose finding study designed to evaluate peginesatide treatment of participants with CKD not on ESA treatment. The objective was to determine the range of doses of peginesatide administered subcutaneously once every 4 weeks (Q4W) that increased and maintained hemoglobin at 11 to 13 g/dL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Research Facility
Bialystok, Poland
Research Facility
Gdansk, Poland
Research Facility
Katowice, Poland
Research Facilities
Percentage of participants who achieved a target hemoglobin response during the study.
A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 11.0 g/dL during the study.
Time frame: 25 weeks
Incidence of adverse events and serious adverse events
Time frame: 25 weeks
Pharmacokinetic parameters
Time frame: 25 weeks
Percentage of participants with hemoglobin values in the range of 11.0 to 13.0 g/dL throughout the study.
Time frame: 25 weeks
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Krakow, Poland
Research Facility
Lodz, Poland
Research Facility
Warsaw, Poland
Research Facility
Coventry, United Kingdom
Research Facility
Croydon, United Kingdom
Research Facility
Derby, United Kingdom
Research Facility
Leicester, United Kingdom
...and 3 more locations