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Clinical Trial Details

Trial ID: L0571
Source ID: NCT00228436
Associated Drug: Peginesatide
Title: Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia|Chronic Kidney Disease|Chronic Renal Failure
Interventions: DRUG: peginesatide
Outcome Measures: Primary: 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., 25 weeks | Secondary: Incidence of adverse events and serious adverse events, 25 weeks|Pharmacokinetic parameters, 25 weeks|Percentage of participants with hemoglobin values in the range of 11.0 to 13.0 g/dL throughout the study., 25 weeks
Sponsor/Collaborators: Sponsor: Affymax
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 139
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-09
Completion Date: 2007-11
Results First Posted:
Last Update Posted: 2012-12-21
Locations: Research Facility, Białystok, Poland|Research Facility, Gdansk, Poland|Research Facility, Katowice, Poland|Research Facilities, Kraków, Poland|Research Facility, Warszawa, Poland|Research Facility, Łódź, Poland|Research Facility, Coventry, United Kingdom|Research Facility, Croydon, United Kingdom|Research Facility, Derby, United Kingdom|Research Facility, Leicester, United Kingdom|Research Facilities, London, United Kingdom|Research Facility, Salford, United Kingdom|Research Facility, Swansea, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00228436

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress