The following metadata was extracted using Predictive Analytics Framework

Attribute	Details
Title	Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa.
Authors	Fishbane S, Roger SD, Martin E, Runyan G, O’Neil J, Qiu P, Locatelli F

Attribute	Description
Study Design	Open-label, multicenter, single-arm study evaluating hemoglobin level maintenance in CKD patients after conversion from darbepoetin alfa to peginesatide.
Disease State	Chronic kidney disease (CKD) with anemia.
Treatment	Peginesatide (Omontys), a synthetic, PEGylated, peptide-based erythropoiesis-stimulating agent.
Treatment Group	Two groups: CKD patients on hemodialysis (HD) and CKD patients not on dialysis (CKD-ND).
Gender	HD group: 67.3% men; CKD-ND group: 32.7% men.
Dosage	Peginesatide starting dose based on prior darbepoetin alfa dosage, adjusted to maintain Hb levels within target range; specific dosages mentioned: <0.5 μg/kg per week darbepoetin alfa to 0.04 mg/kg once-monthly peginesatide, up to ≥1.5 μg/kg per week to 0.16 mg/kg.
Subject Population	Adults with stable doses of darbepoetin alfa for at least 8 weeks before enrollment, stable Hb levels, and adequate iron stores. Exclusions included certain comorbidities.
Comorbidities	Exclusion of known bleeding or coagulation disorder, poorly controlled hypertension, advanced CHF, uncontrolled or symptomatic inflammatory disease, seizure disorder, or active malignancy.
Healthcare Utilization	Data on red blood cell transfusions and adverse events. HD group: 5.8% received transfusions; CKD-ND group: 2.0%.
Treatment Patterns	Patients were converted from darbepoetin alfa to once-monthly peginesatide; dosage adjustments based on Hb levels.
Genomic/Biomarker Data	No genomic information or biomarkers used to assess treatment response mentioned.
Disease Progression	Focus on maintaining hemoglobin levels within target range in CKD patients; specific changes in hemoglobin levels reported.
Patient Satisfaction and Preferences	Not discussed, though a potential benefit of less frequent dosing is mentioned regarding reduced injection-related personnel time and more time for patient education.

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Attribute	Details
Title	A Population Pharmacokinetic and Pharmacodynamic Analysis of Peginesatide in Patients with Chronic Kidney Disease on Dialysis
Authors	Naik H, Tsai MC, Fiedler-Kelly J, Qiu P, Vakilynejad M

Attribute	Details
Study Design	Population pharmacokinetic and pharmacodynamic model development using NONMEM VI based on data from Phase 2 and Phase 3 clinical trials. Two-compartment model with first-order absorption and saturable elimination for PK; modified precursor-dependent lifespan indirect response model for PD.
Disease State	Chronic kidney disease (CKD), including patients on dialysis.
Treatment	Peginesatide (OMONTYS®), an erythropoiesis-stimulating agent, for the treatment of anemia due to CKD in adult patients on dialysis. Doses ranged from 0.03 to 0.16 mg/kg for both intravenous (IV) and subcutaneous (SC) administration.
Treatment Group	Patients with CKD on or not on dialysis. Hemodialysis patients were a subset of the total CKD population studied.
Gender	60.7% male and 39.3% female in the PK population (672 patients). 61.5% male and 38.5% female in the PK-PD population (517 patients).
Dosage	Peginesatide doses for IV or SC administration ranged from 0.03 to 0.16 mg/kg.
Subject Population	Adult patients with chronic kidney disease, including both dialysis and non-dialysis patients. Age ranged from 21 to 93 years, with a mean age of 58.4 years in the PK population and 57.9 years in the PK-PD population.
Comorbidities	Information on specific comorbidities was not provided in detail, but common conditions associated with CKD (e.g., hypertension, diabetes) can be inferred. The presence of concomitant medications such as ACE inhibitors, antidiabetics, beta-blockers, and others indicate the presence of various comorbidities.
Healthcare Utilization	Not explicitly detailed, but the use of concomitant medications and the mention of treatments for conditions such as congestive heart failure and arrhythmia indicate healthcare utilization by the study population.
Treatment Patterns	Peginesatide was administered either IV or SC, with dosing every 4 weeks. Specific dose adjustments based on hemoglobin levels and patient response to treatment were implemented.
Drug Interactions	No significant drug-drug interactions were identified through the evaluation of concomitant medications.
Disease Progression	CKD often progresses and may result in end-stage renal disease (ESRD), necessitating dialysis or kidney transplantation. The study population included both dialysis and non-dialysis patients, indicating various stages of disease progression.