AnemiaPhase 2/3NCT00318812

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

A Phase 2/3 study testing Heme Iron Polypeptide (Proferrin) and Iron sucrose (Venofer) in people with Anemia and Renal Failure, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Renal Failure
What is being tested?: Heme Iron Polypeptide (Proferrin) and Iron sucrose (Venofer)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteCanada
Study dates: May 2007to Dec 2011
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9

Other trials in Canada

About this study

Official title: Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

Read the detailed description

Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.

Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Conditions: Anemia, Renal Failure
Being tested: Heme Iron Polypeptide (Proferrin), Iron sucrose (Venofer)
Keywords: Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant, Ferritin, Transferrin, Treatment Outcome
Medical subject headings: Anemia, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heme Iron Polypeptide (Proferrin)Drug
Also called Proferrin
Heme iron polypeptide 11mg po tid for 6 months
Iron sucrose (Venofer)Drug
Also called Venofer
Iron sucrose infusion IV q month x 6 months

Study groups in NCT00318812
Study group	Role	What they receive
Heme Iron	Experimental	Heme Iron Polypeptide 11mg PO tid for 6 months Receives: Drug: Heme Iron Polypeptide (Proferrin)
Venofer	Active comparator	Venofer q month IV x 6 months Receives: Drug: Iron sucrose (Venofer)

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin Concentration at 6 Months
Measured: 6 months

Secondary outcomes (2)

Ferritin
Comparison of Ferritin at 6 months between the 2 Groups
Measured: 6 months
Transferrin Saturation
Comparison of Transferrin Saturation between the Groups
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Dec 2011

First posted27 Apr 2006 (estimated)
Study startMay 2007
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00318812
Sponsor's protocol ID: 2005840-01H
Status last verified: Apr 2016
First submitted: 25 Apr 2006
Last updated: 10 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23514036

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study
ClinicalTrials.gov ID: NCT00318812
Acronym / sponsor ID: 2005840-01H
Conditions: Anemia, Renal Failure
Keywords: Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: May 2007
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 27 Apr 2006 (estimated)
Results: Posted 2 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Heme Iron	Experimental	Drug: Heme Iron Polypeptide (Proferrin)Heme Iron Polypeptide 11mg PO tid for 6 months
Venofer	Active comparator	Drug: Iron sucrose (Venofer)Venofer q month IV x 6 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Heme Iron Polypeptide (Proferrin)Also: ProferrinHeme iron polypeptide 11mg po tid for 6 months	Drug	Heme Iron
Iron sucrose (Venofer)Also: VenoferIron sucrose infusion IV q month x 6 months	Drug	Venofer

Primary outcome

Hemoglobin Concentration at 6 Months
Time frame: 6 months

2 secondary outcomes

Ferritin
Time frame: 6 months
Transferrin Saturation
Time frame: 6 Months

Results and safety

Results posted to the registry on 2 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Heme Iron	18	18
Iron Sucrose	22	22

Primary outcome: Hemoglobin Concentration at 6 Months

Time frame: 6 months. Median (Inter-Quartile Range). Unit: g/L

Measure	Heme Iron n = 18	Iron Sucrose n = 22
Value	117 (110 to 129)	113 (108 to 120)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Heme Iron	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Iron Sucrose	0 of 22 (0%)	4 of 22 (18.2%)	Not reported

Limitations and caveats (from the sponsor): Recruitment for the trial was a challenge; over 1100 patients screened - 55 consented - 40 randomized

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23514036Nagaraju 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.

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The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah Zimmerman, MD principal investigator

Ottawa Hospital Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Heme Iron Polypeptide (Proferrin) and Iron sucrose (Venofer) in people with Anemia and Renal Failure, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin Concentration at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00318812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.