None listed
Conditions
Brief summary
The main hypothesis of the study is that Heme Iron Polypeptide [HIP; Proferrin (registered trademark) ES] administration will more effectively augment iron stores in erythropoeitin stimulating agent-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation [Ferrogradumet (Registered Trademark)]. Patients will be randomized to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) orally for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During this 6 month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly (as per usual clinical practice). Patients will be reviewed by PD nursing staff monthly and by nephrologists bi-monthly (as per usual clinical practice). 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. Secondary outcome measures will include serum ferritin concentration, haemoglobin level, darbapoeitin dosage, Key’s index (darbapoetin dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events).
Interventions
Administration of oral Heme Iron Polypeptide [HIP; Proferrin (Registered trademark) ES, Colorado Biolabs, USA] 12mg (1 tablet) twice daily for 6 months
Sponsors
Professor David Johnson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. On peritoneal dialysis for 1 month or longer. 2. On DPO for 1 month or longer. 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 > 100 pmol/L. 8. Serum aluminium > 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 500 microgram/mL or greater or transferrin saturation (TSAT) 50% or greater. 13. Religious or other objection to consuming product prepared from bovine blood.
Outcome results
None listed