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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838097
• Other study ID #: 20070211
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: July 29, 2014
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Statni ustav pro kontrolu lecivEU: CHMPSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)	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).	2 years	Yes
Secondary	Hemoglobin Concentration by Three Monthly Intervals		Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24	No
Secondary	Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals	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.	Baseline and Months 1 to 24	No
Secondary	Parathyroid Hormone Level by Three Monthly Intervals		Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24	No
Secondary	Number of Participants With Non-serious Adverse Drug Reactions (ADRs)	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.	2 years	No

External Links

•   AmgenTrials clinical trials website