None listed
Conditions
Brief summary
90% of subjects undergoing dialysis for chronic kidney disease (CKD) require regular treatment of anaemia with iron and erythropoiesis stimulating agents (ESAs), costing in excess of $150 million per year. Anaemia results from deficient production of erythropoietin and reduced Fe absorption and utilization. The latter results from excessive production of hepcidin in response to elevated interleukin 6 (IL6) levels. Recently, we conducted a 4-week pilot study of pentoxifylline (PTF) in anaemic patients with CKD and showed it was effective at reducing serum IL6 levels and improving haemoglobin levels. In this study we will determine longer-term efficacy by administering PTF to anaemic CKD patients for 6 months. If successful, we would recommend that therapy with PTF, which is 5% the cost of ESA therapy, could become the standard of care.
Interventions
Serial measurements of haematological parameters, serum Fe biochemistry, hepcidin, multiple pro-inflammatory cytokines (via multiplex cytokine array ELISA including IL6, IL1Beta, IFNBeta, TNF) and erythropoietin levels will be undertaken in our laboratories at Fremantle Hospital.
There will be a 1 month run-in period during which these parameters will be monitored at t=-4 weeks and t=0 weeks (When study medication will commence). Study medication will be Pentoxifylline (Trental) or matching pla
Serial measurements of haematological parameters, serum Fe biochemistry, hepcidin, multiple pro-inflammatory cytokines (via multiplex cytokine array ELISA including IL6, IL1Beta, IFNBeta, TNF) and erythropoietin levels will be undertaken in our laboratories at Fremantle Hospital. There will be a 1 month run-in period during which these parameters will be monitored at t=-4 weeks and t=0 weeks (When study medication will commence). Study medication will be Pentoxifylline (Trental) or matching placebo 400mg twice a day orally for 6 months. Thereafter patients will be clinically reviewed every month with blood samples obtained monthly up to 6 months.
Sponsors
Professor John OLYNYK FRACP MD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed