A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)

Phase 3

Recruiting

• Conditions: Iron deficiency anaemia; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12609000432213
• Lead Sponsor: Professor David Johnson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transferrin saturation (TSAT) values measured via blood analysis[At baseline then every 2 months for 6 months]