Rationale and design of the oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets trial for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial).
BACKGROUND
The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin ES) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet).


METHODS
Inclusion criteria are peritoneal dialysis patients treated with darbepoietin alpha (DPO; Aranesp(R), Amgen) for >or= 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).


CONCLUSIONS
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.


BACKGROUND
Australia New Zealand Clinical Trials Registry number ACTRN12609000432213.
Barraclough
Katherine A
KA
Department of Nephrology, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia. katherine_barraclough@health.qld.gov.au
Noble
Euan
E
Leary
Diana
D
Brown
Fiona
F
Hawley
Carmel M
CM
Campbell
Scott B
SB
Isbel
Nicole M
NM
Mudge
David W
DW
van Eps
Carolyn L
CL
Sturtevant
Joanna M
JM
Johnson
David W
DW
D000284:Administration, Oral; D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D001315:Australia; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004921:Erythropoietin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005293:Ferritins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D005296:Ferrous Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000627:therapeutic use; D006420:Hemeproteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007501:Iron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000150:complications* / Q000628:therapy*; D010530:Peritoneal Dialysis; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D005296:Ferrous Compounds; D006397:Hematinics; D006420:Hemeproteins; D006454:Hemoglobins; C073694:haemoferritin; D004921:Erythropoietin; D000068256:Darbepoetin alfa; C020748:ferrous sulfate; D005293:Ferritins; D007501:Iron