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Hematinics

Chrysarobin

Epoetin Alfa

Peginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses.

Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.

peginesatide

Affymax

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.

This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Kidney Diseases

Kidney Failure, Chronic

Renal Insufficiency

Renal Insufficiency, Chronic

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Single injection administered intravenously

Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Placebo

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.

Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy	NCT00272662	Chemotherapy In... Cancer	peginesatide	18 Years - 80 Years	Affymax
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers	NCT00097747	Anemia Chronic Kidney ... Chronic Renal F... Cancer	Placebo peginesatide	18 Years - 40 Years	Affymax

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