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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

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:
- Fatal
- Life threatening
- Required or prolonged in-patient hospitalization
- A persistent or significant disability/incapacity, or
- A congenital anomaly/birth defect.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Feb 6, 2009
Registry last updated: Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed