HEMATOCRIT Trial: 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

Phase 4

Completed

• Conditions: darbepoetin-treated peritoneal dialysis patients; Anaemia in peritoneal dialysis patients treated with darbepoetin; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000678099
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the difference in transferrin saturation (TSAT) values between the HIP and ferrous sulphate groups at the end of the 6 month study period.[At the end of the study (6 months)]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures will be the differences between the 2 groups at the end of the 6 month study period with respect to serum ferritin concentration, haemoglobin level, darbepoetin (DPO) dosage, Key's index (DPO dosage divided by haemoglobin) and incidence of adverse events.[At the end of the study (6 months)]