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

NCT ID: NCT00664066

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-25
• Study Completion Date: 2008-07-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

DYNEPO (epoetin delta)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Nephrologische Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Hanse-Klinikum Stralsund

Stralsund, , Germany

Countries

Germany

Other Identifiers

SPD490-404

Identifier Type: -

Identifier Source: org_study_id