ESAs, Reticulocyte Dynamic and Hemoglobin Variability

Sponsor

Ospedale Regionale di Locarno (Other)

Overall Status

Completed

CT.gov ID

NCT01666301

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erythropoiesis Stimulating Agent Pharmacodynamics	Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: C.E.R.A. C.E.R.A. every 4 and then every 2 weeks	Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
Active Comparator: Darbepoetin Darbepoetin alfa every 4 and then every 2 weeks	Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals

Arm

Intervention/Treatment

Active Comparator: C.E.R.A.

C.E.R.A. every 4 and then every 2 weeks

Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals

Active Comparator: Darbepoetin

Darbepoetin alfa every 4 and then every 2 weeks

Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals

Outcome Measures

Primary Outcome Measures

hemoglobin variability [2 years]

Secondary Outcome Measures

differences in reticulocyte count over time [2 years]
risk of hemoglobin overshooting (HR) [2 years]
superiority of every 2 week administration [2 years]
reticulocyte variability [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Regionale Locarno	Locarno	Ticino	Switzerland	6600

Sponsors and Collaborators

Ospedale Regionale di Locarno

Investigators

Principal Investigator: Luca Gabutti, MD, Ospedale Regionale Locarno

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luca Gabutti, MD, Head of Department; internal medicine, Ospedale Regionale di Locarno

ClinicalTrials.gov Identifier:

NCT01666301

Other Study ID Numbers:

Epo-Loc1

First Posted:

Aug 16, 2012

Last Update Posted:

Aug 17, 2012

Last Verified:

Aug 1, 2012

Keywords provided by Luca Gabutti, MD, Head of Department; internal medicine, Ospedale Regionale di Locarno

Erythropoietin stimulating agents

Hemoglobin

Reticulocytes

Variability

Additional relevant MeSH terms:

Darbepoetin alfa

Study Results

No Results Posted as of Aug 17, 2012