Darbepoetin Administration to Preterm Infants

NCT00334737 | Completed Phase 2 Results DMC

• 1 other identifier: 06-139
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief Summary

Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.

Conditions

Infant, Newborn

Keywords

erythropoietin; darbepoetin; transfusions; neonates; outcomes; neurodevelopment

Outcome Measures

Primary Outcomes (2)

• Number of Transfusions During Hospitalization

  From birth to 36 weeks gestational age

• Composite Cognitive Score at 18-22 Months Corrected Age

  Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.

  18-22 months

Secondary Outcomes (7)

• Hematocrit

  From birth to 36 weeks gestational age

• Reticulocyte Count

  at day 60 of study

• Volume of Transfusions

  From birth to 36 weeks gestational age

• Epo Concentrations

  peak from birth to 36 weeks gestational age

• Object Permanence Scores at 18-22 Months

  18-22 months

Study Arms (3)

Darbepoetin alfa injection

EXPERIMENTAL

Darbepoetin alfa 10 mics/kg/week subcutaneous injection x 10 weeks or until 35 completed weeks Drug: Darbepoetin alfa Other names: Aranesp Darbe SC injection

Drug: Darbepoetin Alfa Injection

erythropoietin alfa injection

ACTIVE COMPARATOR

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks Drug: erythropoietin other names: epogen Epo SC injection

Drug: erythropoietin alfa injection

placebo/control

PLACEBO COMPARATOR

Sham injection

Drug: sham injection

Interventions

Darbepoetin Alfa Injection DRUG

darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Also known as: aranesp, Darbe

Darbepoetin alfa injection

erythropoietin alfa injection DRUG

Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Also known as: procrit, epoetin alfa

erythropoietin alfa injection

sham injection DRUG

sham injection other names: not applicable

Also known as: placebo

placebo/control

Eligibility Criteria

• Age: 1 Hour - 49 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• grams birth weight
• less than or equal to 32 weeks gestation
• less than 2 days of age

You may not qualify if:

• severe hemorrhagic disease
• severe hemolytic disease
• DIC
• seizures
• hypertension
• thromboses
• receiving erythropoietin

Sponsors & Collaborators

• University of New Mexico: lead
• Thrasher Research Fund: collaborator
• University of Colorado, Denver: collaborator
• Intermountain Health Care, Inc.: collaborator

Study Sites (3)

University of Colorado

Denver, Colorado, 80218, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

LDS Hospital

Salt Lake City, Utah, 84103, United States

Location

Related Publications (6)

• Warwood TL, Ohls RK, Wiedmeier SE, Lambert DK, Jones C, Scoffield SH, Neeraj G, Veng-Pedersen P, Christensen RD. Single-dose darbepoetin administration to anemic preterm neonates. J Perinatol. 2005 Nov;25(11):725-30. doi: 10.1038/sj.jp.7211387.

  PMID: 16151471 BACKGROUND

• Ohls RK, Dai A. Long-acting erythropoietin: clinical studies and potential uses in neonates. Clin Perinatol. 2004 Mar;31(1):77-89. doi: 10.1016/j.clp.2004.03.006.

  PMID: 15183658 BACKGROUND

• Warwood TL, Ohls RK, Lambert DK, Jones C, Scoffield SH, Gupta N, Veng-Pedersen P, Christensen RD. Intravenous administration of darbepoetin to NICU patients. J Perinatol. 2006 May;26(5):296-300. doi: 10.1038/sj.jp.7211498.

  PMID: 16554846 BACKGROUND

• Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91. doi: 10.1542/peds.2003-1129-L.

  PMID: 15520109 BACKGROUND

• Lowe JR, Rieger RE, Moss NC, Yeo RA, Winter S, Patel S, Phillips J, Campbell R, Baker S, Gonzales S, Ohls RK. Impact of Erythropoiesis-Stimulating Agents on Behavioral Measures in Children Born Preterm. J Pediatr. 2017 May;184:75-80.e1. doi: 10.1016/j.jpeds.2017.01.020. Epub 2017 Feb 6.

  PMID: 28185625 DERIVED

• Ohls RK, Cannon DC, Phillips J, Caprihan A, Patel S, Winter S, Steffen M, Yeo RA, Campbell R, Wiedmeier S, Baker S, Gonzales S, Lowe J. Preschool Assessment of Preterm Infants Treated With Darbepoetin and Erythropoietin. Pediatrics. 2016 Mar;137(3):e20153859. doi: 10.1542/peds.2015-3859. Epub 2016 Feb 15.

  PMID: 26908704 DERIVED

MeSH Terms

Interventions

Darbepoetin alfa; Epoetin Alfa; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Dr. Robin K Ohls
• Organization: University of New Mexico

rohls@salud.unm.edu

505-272-6753

Study Officials

• Robin K Ohls, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Robert D Christensen, MD

  McKay-Dee Hospital, Ogden, Utah

  PRINCIPAL INVESTIGATOR

• Susan Wiedmeier, MD

  LDS Hospital, Salt Lake City, Utah

  PRINCIPAL INVESTIGATOR

• Adam Rosenberg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 4, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-01

Locations

US (3)