Evaluation of a new and more cost-effective treatment option for anaemia of chronic kidney disease.

Phase 4

Completed

• Conditions: Renal Anaemia; Renal and Urogenital - Kidney disease; Blood - Anaemia

• Registration Number: ACTRN12612001018808
• Lead Sponsor: Professor John OLYNYK FRACP MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients will be eligible for inclusion if they fulfil the following criteria: between 18 and 80 years of age; glomerular filtration rate < 45 ml/min, stable known renal function over last 12 months; not requiring haemodialysis; haemoglobin < 120 g/L(Female), <130 g/L(Male); ferritin > 100 microg/L or transferrin saturation > 20% and not currently receiving ESA.

Exclusion Criteria

Exclusion criteria include: significant co-morbid conditions which in the opinion of the treating nephrologist preclude inclusion in the study; active gastrointestinal bleeding or another source of blood loss; haemolysis or other haematological disorder which reduces haemoglobin level; pregnancy or lactation. Intolerance to methlanthines (eg. caffeine, theophylline), recent peptic ulcer, recent cerebral or retinal haemorhage and acute MI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemoglobin, measured by blood analysis.[Monthly within the 6 months];The need to start erythropoiesis stimulating agent/iron therapy by end of study (yes/no and total dose of each), measured by clinical assessment and blood analysis.[6 months.]

Secondary Outcome Measures

Name	Time	Method
il[Nil]