N/A
Completed N=321
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
Source: ClinicalTrials.gov NCT00838097 ↗Enrolled (actual)
321
Serious AEs
50.8%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) — 4; 162; 39 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) |
4; 162; 39 | — |
| SECONDARY Hemoglobin Concentration by Three Monthly Intervals |
11.06; 11.47; 11.34; 11.43; 11.39; 11.26 | — |
| SECONDARY Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals |
1.99; 1.90; 1.91; 1.94; 1.87; 1.82 | — |
| SECONDARY Parathyroid Hormone Level by Three Monthly Intervals |
20.44; 19.76; 18.12; 16.70; 19.11; 17.51 | — |
| SECONDARY Number of Participants With Non-serious Adverse Drug Reactions (ADRs) |
4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00838097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.