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

NCT00838097 | Completed Results

• 1 other identifier: 20070211
• Study Type: observational
• Target: 321
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

CKD; Paediatric; Darbepoetin Alfa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Hemoglobin Concentration by Three Monthly Intervals

  Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24

• Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals

  Baseline and Months 1 to 24

• Parathyroid Hormone Level by Three Monthly Intervals

  Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24

• Number of Participants With Non-serious Adverse Drug Reactions (ADRs)

  2 years

Study Arms (1)

Darbepoetin alfa

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

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Specialist Centres

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: July 9, 2014

Record last verified: 2014-07