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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838097