ESAs, Reticulocyte Dynamic and Hemoglobin Variability

NCT01666301 | Completed

• 1 other identifier: Epo-Loc1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythropoiesis Stimulating Agent Pharmacodynamics

Keywords

Erythropoietin stimulating agents; Hemoglobin; Reticulocytes; Variability

Outcome Measures

Primary Outcomes (1)

• hemoglobin variability

  2 years

Secondary Outcomes (4)

• 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

Study Arms (2)

C.E.R.A.

ACTIVE COMPARATOR

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

Darbepoetin

ACTIVE COMPARATOR

Darbepoetin alfa every 4 and then every 2 weeks

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

Interventions

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

C.E.R.A.; Darbepoetin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ospedale Regionale di Locarno: lead

Study Sites (1)

Ospedale Regionale Locarno

Locarno, Canton Ticino, 6600, Switzerland

Location

Related Publications (1)

• Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, Gabutti L. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol. 2013 Jul 22;14:157. doi: 10.1186/1471-2369-14-157.

  PMID: 23870287 DERIVED

Study Officials

• Luca Gabutti, MD

  Ospedale Regionale Locarno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department; internal medicine

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

CH (1)