NCT00318812

Brief Summary

The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 2, 2014

Completed
Last Updated

May 10, 2016

Status Verified

April 1, 2016

Enrollment Period

4.6 years

First QC Date

April 25, 2006

Results QC Date

June 26, 2013

Last Update Submit

April 5, 2016

Conditions

AnemiaRenal Failure

Keywords

Randomized controlled trial (RCT)Prospective Studiesferric oxide, saccharatedPeptidesHemeIronErythropoietin,RecombinantFerritinTransferrinTreatment Outcome

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin Concentration at 6 Months

    6 months

Secondary Outcomes (2)

  • Ferritin

    6 months

  • Transferrin Saturation

    6 Months

Study Arms (2)

Heme Iron

EXPERIMENTAL

Heme Iron Polypeptide 11mg PO tid for 6 months

Drug: Heme Iron Polypeptide (Proferrin)

Venofer

ACTIVE COMPARATOR

Venofer q month IV x 6 months

Drug: Iron sucrose (Venofer)

Interventions

Heme Iron Polypeptide (Proferrin)DRUG

Heme iron polypeptide 11mg po tid for 6 months

Also known as: Proferrin
Heme Iron
Iron sucrose (Venofer)DRUG

Iron sucrose infusion IV q month x 6 months

Also known as: Venofer
Venofer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eGFR \< 30 mL/min
  • Hb 90-110 g/L
  • Age \> 18
  • Not on renal replacement therapy
  • Transferrin saturation \< 20% OR Ferritin \<100 mcg/L
  • B12 \& folate within reference range

You may not qualify if:

  • Iron overload (Tsat \> 50% or ferritin \> 800 μg/L);
  • malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
  • parenteral iron therapy, blood transfusion within the last 3 months;
  • pregnancy;
  • contraindication to any study medication and;
  • inability or refusal to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (1)

  • Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.

    PMID: 23514036DERIVED

MeSH Terms

Conditions

AnemiaRenal Insufficiency

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Limitations and Caveats

Recruitment for the trial was a challenge; over 1100 patients screened - 55 consented - 40 randomized

Results Point of Contact

Title
Dr Deborah Zimmerman, principal investigator
Organization
Ottawa Hospital Research Institute
dzimmerman@toh.on.ca
613-738-8400

Study Officials

  • Deborah Zimmerman, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

May 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 10, 2016

Results First Posted

May 2, 2014

Record last verified: 2016-04

Locations

CA(1)