Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Brief Summary: 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.


Options:
A: Arm Label: C.E.R.A.; Type: ACTIVE_COMPARATOR; Interventions: Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals | Arm Label: Darbepoetin; Type: ACTIVE_COMPARATOR; Interventions: Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals | Intervention Type: DRUG; Name: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals; Assigned to Arm(s): C.E.R.A., Darbepoetin
B: Arm Label: MIRCERA; Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Darbepoetin Alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin Alfa | Intervention Type: DRUG; Name: methoxy polyethylene glycol-epoetin beta [Mircera]; Assigned to Arm(s): MIRCERA
C: Arm Label: ESAs 1 low dose; Type: EXPERIMENTAL; Interventions: Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. | Arm Label: ESAs 2 high dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. | Intervention Type: DRUG; Name: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.; Assigned to Arm(s): ESAs 1 low dose | Intervention Type: DRUG; Name: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.; Assigned to Arm(s): ESAs 2 high dose
D: Arm Label: Epoetin Hospira; Type: OTHER; Interventions: Biological: Epoetin Hospira Arm, Drug: IV Iron | Arm Label: Standard of Care; Type: OTHER; Interventions: Other: Standard of Care Arm, Drug: IV Iron | Intervention Type: BIOLOGICAL; Name: Epoetin Hospira Arm; Assigned to Arm(s): Epoetin Hospira | Intervention Type: OTHER; Name: Standard of Care Arm; Assigned to Arm(s): Standard of Care | Intervention Type: DRUG; Name: IV Iron; Assigned to Arm(s): Epoetin Hospira, Standard of Care

Answer: A