Erythropoiesis Stimulating Agent Pharmacodynamics Clinical Trial
Official title:
Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
| Verified date | August 2012 |
| Source | Ospedale Regionale di Locarno |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing
the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration
interval decreases hemoglobin variability. The benefit of reducing the administration
interval was however lessened by the variability induced by more frequent dosage
adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin
kinetics under different ESAs and administration intervals in a collective of chronic
hemodialysis patients.
Methods: The study was designed as an open-label, randomized, four-period cross-over
investigation, including 30 patients under chronic hemodialysis at the regional hospital of
Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies
(C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were
compared with each other. The mean square successive difference of hemoglobin, reticulocyte
count and ESAs dose was used to quantify variability. We distinguished a short- and a
long-term variability based respectively on the weekly and monthly successive difference.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - chronic patients aged 18 years or older, undergoing dialysis 3 times a week for at least 8 weeks before screening, necessitating continuous subcutaneous treatment with weekly Darbepoetin alfa or Erythropoietin beta to maintain hemoglobin (Hb) targets Exclusion Criteria: - pregnancy; not respecting the inclusion criteria |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Ospedale Regionale Locarno | Locarno | Ticino |
| Lead Sponsor | Collaborator |
|---|---|
| Ospedale Regionale di Locarno |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | hemoglobin variability | 2 years | No | |
| Secondary | differences in reticulocyte count over time | 2 years | No | |
| Secondary | risk of hemoglobin overshooting (HR) | 2 years | No | |
| Secondary | superiority of every 2 week administration | 2 years | No | |
| Secondary | reticulocyte variability | 2 years | No |