Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

NCT00236964

Anemia

COMPLETED PHASE3

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

NCT00236977

Anemia

COMPLETED PHASE3

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

NCT00255437

Anemia

COMPLETED PHASE3

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

NCT00233597

Anemia

COMPLETED PHASE3

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

NCT00224055

Anemia, Iron-Deficiency Kidney Failure, Chronic

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heme Iron

Heme Iron Polypeptide 11mg PO tid for 6 months

Group Type EXPERIMENTAL

Heme Iron Polypeptide (Proferrin)

Intervention Type DRUG

Heme iron polypeptide 11mg po tid for 6 months

Venofer

Venofer q month IV x 6 months

Group Type ACTIVE_COMPARATOR

Iron sucrose (Venofer)

Intervention Type DRUG

Iron sucrose infusion IV q month x 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heme Iron Polypeptide (Proferrin)

Heme iron polypeptide 11mg po tid for 6 months

Intervention Type DRUG

Iron sucrose (Venofer)

Iron sucrose infusion IV q month x 6 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Proferrin Venofer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No