Dynepo Long-Term Safety Study

NCT00514813 | Terminated Phase 4 Results

• 2 other identifiers: SPD490-4022007-000054-31
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

  Over the course of 2 Years

Secondary Outcomes (2)

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

  Baseline and 2 years

• Change From Baseline in Hematocrits at 2 Years

  Baseline and 2 years

Study Arms (1)

Dynepo (Epoetin delta)

EXPERIMENTAL

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

Drug: Dynepo

Interventions

Dynepo DRUG

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

Also known as: Epoetin delta

Dynepo (Epoetin delta)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Heilig Hartziekenhuis Department of Nephrology

Lier, Belgium

Location

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Interventions

Erythropoietin; epoetin delta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 10, 2007
• Study Start: June 6, 2007
• Primary Completion: July 31, 2008
• Study Completion: July 31, 2008
• Last Updated: July 13, 2021
• Results First Posted: November 9, 2009

Record last verified: 2021-06

Locations

BE (1)