European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT00838097
• Lead Sponsor: Amgen

Brief Summary

This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-03-04
• Results First Submitted QC: 2014-06-06
• Status Verified: 2014-07
• Results First Posted: 2014-07-09
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• Anaemia attributed to Chronic Kidney Disease (CKD)
• Sixteen years of age or under
• Documented CKD as demonstrated by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² (Schwartz equation) for ≥3 months if not on dialysis, or: Receiving dialysis
• Treatment with darbepoetin alfa
• Documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate

Exclusion Criteria

• Active malignancy or current chemotherapy or radiation therapy
• Investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment
• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)	2 years	An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).

Secondary Outcome Measures

Name	Time	Method
Parathyroid Hormone Level by Three Monthly Intervals	Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
Hemoglobin Concentration by Three Monthly Intervals	Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals	Baseline and Months 1 to 24	Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.
Number of Participants With Non-serious Adverse Drug Reactions (ADRs)	2 years	An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied: * Fatal; * Life threatening; * Required or prolonged in-patient hospitalization; * A persistent or significant disability/incapacity, or; * A congenital anomaly/birth defect.