European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
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|ClinicalTrials.gov Identifier: NCT00838097|
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : July 9, 2014
Last Update Posted : August 1, 2014
|Condition or disease|
|Chronic Kidney Disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||321 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||A Prospective Registry Study Observing the Safety and Patterns of Use of Darbepoetin Alfa in EU Paediatric Chronic Kidney Disease Patients Receiving or Not Receiving Dialysis|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
- Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) [ Time Frame: 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).
- Hemoglobin Concentration by Three Monthly Intervals [ Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 ]
- Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals [ Time Frame: 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.
- Parathyroid Hormone Level by Three Monthly Intervals [ Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 ]
- Number of Participants With Non-serious Adverse Drug Reactions (ADRs) [ Time Frame: 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:
- Life threatening
- Required or prolonged in-patient hospitalization
- A persistent or significant disability/incapacity, or
- A congenital anomaly/birth defect.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838097