DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

NCT00664066 | Terminated Results

• 1 other identifier: SPD490-404
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.

Conditions

Anemia; Kidney Diseases; Renal Failure, Chronic; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo

  This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.

  up to 3 years

Interventions

DYNEPO (epoetin delta) DRUG

dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits, as this is an observational study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with established Chronic Kidney Disease

You may qualify if:

• Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent.
• Patients must already be receiving DYNEPO treatment at time of study entry.
• Patients who are likely to receive DYNEPO for at least 1 year.

You may not qualify if:

• Known intolerance to EPO of any of its excipients
• Known of suspected Pure Red Cell Aplasia (PRCA)

Sponsors & Collaborators

• Shire: lead

Study Sites (2)

Nephrologische Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany

Location

Hanse-Klinikum Stralsund

Stralsund, Germany

Location

MeSH Terms

Conditions

Anemia; Kidney Diseases; Kidney Failure, Chronic

Interventions

Erythropoietin; epoetin delta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; 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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: April 25, 2008
• Primary Completion: July 30, 2008
• Study Completion: July 30, 2008
• Last Updated: June 25, 2021
• Results First Posted: September 28, 2009

Record last verified: 2021-05

Locations

DE (2)