None listed
Conditions
Brief summary
Background: The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin ES [registered trademark]) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet [registered trademark]). Methods: Inclusion criteria are peritoneal dialysis patients treated with darbepoietin alpha (DPO; Aranesp, Amgen) for at least 1 month. Patients will be randomized 1:1 to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During the 6-month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly. The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance (ANCOVA). Secondary outcome measures will include serum ferritin concentration, haemoglobin level, DPO dosage, Key’s index (DPO dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events). Discussion: This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their peritoneal dialysis patients determine whether HIP administration more effectively augments iron stores in ESP-treated PD patients than conventional oral iron supplementation.
Interventions
Heme iron polypeptide (HIP) (Proferrin ES [registered trademark], Colorado Biolabs, USA) is approved for use as a dietary/nutritional supplement in Canada and the United States of America. The usual dose is 1 tablet (equivalent to 12 mg elemental iron) taken twice or thrice daily, either with or without food. The side effects reported with HIP are similar to those associated with conventional oral iron preparations and include nausea, vomiting and constipation. However, trials in healthy individ
Heme iron polypeptide (HIP) (Proferrin ES [registered trademark], Colorado Biolabs, USA) is approved for use as a dietary/nutritional supplement in Canada and the United States of America. The usual dose is 1 tablet (equivalent to 12 mg elemental iron) taken twice or thrice daily, either with or without food. The side effects reported with HIP are similar to those associated with conventional oral iron preparations and include nausea, vomiting and constipation. However, trials in healthy individuals and in haemodialysis patients suggest that the incidence of such adverse drug reactions is relatively low, possibly due to the different absorption characteristics of heme versus non-heme iron. For example, in a study of 37 haemodialysis patients receiving HIP for 6 months, constipation occurred in 3 (8%) patients and was the only observed adverse effect of the agent. The dose of HIP used in that investigation (3 tablets per day) was 50% higher than that proposed in the present study (2 tablets per day). There are no other published data concerning the side effect profile of HIP in end-stage renal failure patients. Concern has previously been expressed about the possibility of transmission of bovine spongiform encephalopathy (BSE) through the consumption of bovine tissue. Currently, HIP is manufactured from red blood cells of cows of American origin, and both the US Department of Agriculture and Food and Drug Administration (FDA) currently maintain that the United States is free of BSE. In addition, the putative infectious agents for BSE, conformationally shifted neuronal membrane copper-binding proteins called prions, usually are not found in blood. Thus, the risk of BSE from taking HIP is negligible. In thus study, the Proferrin will be taken by patients for a period of 6 months.
Sponsors
Amgen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. On peritoneal dialysis greater than or equal to 1 month. 2. On darbepoetin for greater than or equal to 1 month 3. 18 years or over. 4. Able to give informed consent.
Exclusion criteria
1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. 2. Pregnancy or breast-feeding. 3. Known hypersensitivity to, or intolerance of, oral iron, HIP or DPO. 4. Active peptic ulcer disease. 5. Vitamin B12 or folate deficiency. 6. Recent (within 1 month) acute infection. 7. Parathyroid hormone level greater than 100 pmol/L. 8. Serum aluminium greater than 2 micromol/L. 9. Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy 10. Major surgery, infection, acute myocardial infarction or malignancy within the last 3 months. 11. Intravenous iron therapy, vitamin C therapy, melatonin treatment, androgen therapy or blood transfusion within the previous month. 12. Serum ferritin greater than 500 microg/mL or transferrin saturation (TSAT) greater than 50%. 13. Religious or other objection to consuming product prepared from bovine blood.
Outcome results
None listed