European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
This study has been completed.
Information provided by (Responsible Party):
First received: February 5, 2009
Last updated: July 29, 2014
Last verified: July 2014
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.
||Time Perspective: Prospective
|Target Follow-Up Duration:
||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
Primary Outcome Measures:
- Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|Ages Eligible for Study:
||up to 16 Years (Child)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00838097
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 5, 2009
|Results First Received:
||March 4, 2014
||July 29, 2014
||Czech Republic: Statni ustav pro kontrolu leciv
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Keywords provided by Amgen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Renal Insufficiency, Chronic