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Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT)

NCT00557817 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2010-01-11

No results posted yet for this study

Summary

Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.

Conditions

Interventions

DRUG

Darbepoetin alpha (Aranesp)

Darbepoetin alpha (Aranesp) will be administered subcutaneously (s.c.) at the dose of 300 µg. The first dose will be given on day 28 and the following doses at 2-week intervals around days 42, 56, 70, 84, 98 and 112 post-transplant. Once the target Hb (13 g/dL) has been attained, the dose of Aranesp will be reduced by half to 150 µg. If the Hb increases to \> 14 g/dL, Aranesp will be withheld and resumed at the dose of 150 µg when the Hb decreases \< 13 g/dL. If the Hb decreases to \< 12 g/dL, the dose of Aranesp will be increased to 300 µg again.

DRUG

Iron saccharate (Venofer)

Iron saccharate (Venofer) will be administered intravenously (i.v.) at the dose of 200 mg (2 vials of Venofer) on days 28, 42 and 56 after the transplant. Venofer will be diluted in 250 ml saline and infused over 60 minutes. Iron will be omitted in patients with severe iron overload (serum ferritin \> 2500 µg/L in the absence of inflammation or liver necrosis) or elevated transferrin saturation (TS \> 60%) between days 21 and 56. No iron supplementation will be allowed in arm 1. No iron supplementation will be allowed in arm 2 before day 70 after the transplant. In arms 2 and 3, if patients have evidence of functional iron deficiency (transferrin saturation \< 20%) on day 70 or later, they will receive 300 mg of Venofer over 90 min, for a minimum of 2 doses.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • KU Leuven

    collaborator OTHER

  • Vrije Universiteit Brussel

    collaborator OTHER

  • University of Liege

    lead OTHER

Principal Investigators

  • Yves Beguin, MD, PhD · CHU-ULg

  • Frederic Baron, MD, PhD · CHU-ULg

  • Johan Maertens, MD, PhD · KU Leuven

  • Rik Schots, MD · Vrije Universiteit Brussel

  • Bernard DePrijck, MD · CHR Citadelle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557817 on ClinicalTrials.gov