Clinical Trial Details
| Trial ID: | L0563 |
| Source ID: | NCT00109291 |
| Associated Drug: | Placebo |
| Title: | Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia|Chronic Kidney Disease|Chronic Renal Failure |
| Interventions: | DRUG: Placebo|DRUG: peginesatide |
| Outcome Measures: | Primary: Incidence of adverse events and serious adverse events, 28 days | Secondary: Pharmacokinetic parameters, Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-∞, t½ß, Vd, Vss, and Cl, 28 days|Pharmacodynamic parameters, Pharmacodynamic parameters including reticulocytes, hemoglobin, reticulocyte hemoglobin content, and serum measures of iron stores (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein), 28 days |
| Sponsor/Collaborators: | Sponsor: Affymax |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 17 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2005-03 |
| Completion Date: | 2006-02 |
| Results First Posted: | |
| Last Update Posted: | 2012-12-21 |
| Locations: | Research Facility, London, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00109291 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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