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Dynepo Long-Term Safety Study

Primary Purpose

Anemia, Kidney Failure, Chronic

Status

Terminated

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Dynepo

About this trial

This is an interventional other trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who complete Dynepo study SPD490-301.
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:

Withdrawal, before Week 24, from study SPD490-301.
Pregnant or lactating women.
Uncontrolled hypertension.
Thrombocytopenia (platelet count <75,000/mm3).
Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
Androgen therapy in the 30 days immediately prior to enrolment in this study.
Known Human Immunodeficiency Virus (HIV) infection.
History of hypersensitivity to Dynepo.
Known to have Ab against EPO.

Sites / Locations

Heilig Hartziekenhuis Department of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynepo (Epoetin delta)

Arm Description

Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject

Outcomes

Primary Outcome Measures

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

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

Change From Baseline in Hematocrits at 2 Years

Full Information

NCT ID

NCT00514813

First Posted

August 9, 2007

Last Updated

June 21, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00514813

Brief Title

Dynepo Long-Term Safety Study

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 Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA

Study Start Date

June 6, 2007 (Actual)

Primary Completion Date

July 31, 2008 (Actual)

Study Completion Date

July 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Kidney Failure, Chronic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dynepo (Epoetin delta)

Arm Type

Experimental

Arm Description

Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject

Intervention Type

Drug

Intervention Name(s)

Dynepo

Other Intervention Name(s)

Epoetin delta

Intervention Description

Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject

Primary Outcome Measure Information:

Title

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

Time Frame

Over the course of 2 Years

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline and 2 years

Title

Change From Baseline in Hematocrits at 2 Years

Time Frame

Baseline and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who complete Dynepo study SPD490-301. 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: Withdrawal, before Week 24, from study SPD490-301. Pregnant or lactating women. Uncontrolled hypertension. Thrombocytopenia (platelet count <75,000/mm3). Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding). Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study. Androgen therapy in the 30 days immediately prior to enrolment in this study. Known Human Immunodeficiency Virus (HIV) infection. History of hypersensitivity to Dynepo. Known to have Ab against EPO.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Heilig Hartziekenhuis Department of Nephrology

City

Lier

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Dynepo Long-Term Safety Study

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