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

July 29, 2014 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Chronic Kidney Disease

Study Type

Observational

Enrollment (Actual)

321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Specialist Centres

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Darbepoetin alfa Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Concentration by Three Monthly Intervals Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24		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.	Baseline and Months 1 to 24
Parathyroid Hormone Level by Three Monthly Intervals Time Frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24		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.	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

AmgenTrials clinical trials website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria