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Dynepo Long-Term Safety Study

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Kidney Failure, Chronic

Intervention: Dynepo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Iain C Macdougall, MD, Principal Investigator, Affiliation: Kings College Hospital, London

Summary

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Clinical Details

Official title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

Secondary outcome:

Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years

Change From Baseline in Hematocrits at 2 Years

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients who complete Dynepo study SPD490-301. 2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301. Exclusion Criteria: 1. Withdrawal, before Week 24, from study SPD490-301. 2. Pregnant or lactating women. 3. Uncontrolled hypertension. 4. Thrombocytopenia (platelet count <75,000/mm3). 5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding). 6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study. 7. Androgen therapy in the 30 days immediately prior to enrolment in this study. 8. Known Human Immunodeficiency Virus (HIV) infection. 9. History of hypersensitivity to Dynepo. 10. Known to have Ab against EPO.

Locations and Contacts

Department of Nephrology, Heilig Hartziekenhuis, Wilgenstraat 2, Belgium
Additional Information

Starting date: June 2007
Last updated: June 6, 2014

Page last updated: August 23, 2015

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