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ESAs, Reticulocyte Dynamic and Hemoglobin Variability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luca Gabutti, MD, Ospedale Regionale di Locarno
ClinicalTrials.gov Identifier:
NCT01666301
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Erythropoiesis Stimulating Agent Pharmacodynamics
 Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Ospedale Regionale di Locarno:

Primary Outcome Measures:
  • hemoglobin variability [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • differences in reticulocyte count over time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • risk of hemoglobin overshooting (HR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • superiority of every 2 week administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • reticulocyte variability [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666301

Locations
Switzerland
Ospedale Regionale Locarno
Locarno, Ticino, Switzerland, 6600
Sponsors and Collaborators
Ospedale Regionale di Locarno
Investigators
Principal Investigator: Luca Gabutti, MD Ospedale Regionale Locarno
  More Information

No publications provided

Responsible Party: Luca Gabutti, MD, Head of Department; internal medicine, Ospedale Regionale di Locarno
ClinicalTrials.gov Identifier: NCT01666301     History of Changes
Other Study ID Numbers: Epo-Loc1
Study First Received: August 14, 2012
Last Updated: August 16, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Ospedale Regionale di Locarno:
Erythropoietin stimulating agents
Hemoglobin
Reticulocytes
Variability

Additional relevant MeSH terms:
Darbepoetin alfa
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013