None listed
Conditions
Brief summary
Low red blood cell counts (anaemia) occur in the vast majority of patients with chronic kidney disease. In most cases, these low red blood cell counts respond to treatment with medications, such as erythropoietin (Eprex®) or darbepoietin alpha (Aranesp®). However, about 10-15% of patients continue to be anaemic even with appropriate treatment. Such patients are at increased risk of being hospitalized, developing complications such as heart failure, and dying. A number of small studies have suggested that a drug called oxpentifylline (Trental®) is very good at safely raising red blood cell counts in persistently anaemic patients. However, this drug has not yet been properly tested in a controlled trial (that is, where the drug is given to 1 group of patients, but not another).
Interventions
400mg Oxpentifylline tablets daily for 4 months
Sponsors
Australasian Kidney Trials Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Stage 4 or 5 chronic kidney disease 2. Haemoblobin concentration less than or equal to120 g/L 3. ERI greater than or equal to1.0 IU/kg/week/gHb for Erythopoietin (EPO) treated patients and greater than or equal to 0.005 micrograms/kg/week/g Hb for darbepoetin (DPO) treated patients. 4. Stable EPO or DPO dosage for at least 8 weeks. 5. 18 years or over. 6. 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, oxpentifylline or other methylxanthines such as caffeine, theophylline or theobromine 4. History of major gastrointestinal bleeding or any gastrointestinal bleeding in the past 12 weeks. 5. Absolute or functional iron deficiency (ferritin less than 100 microg/L and/or transferrin saturation less than 20%) 6. Vitamin B12 or folate deficiency 7. Parathyroid hormone level greater than 100 pmol/L 8. Serum aluminium greater than 2 micromol/L 9. Urea reduction ratio less than 65% or single pool Kt/V less than 1.0 (haemodialysis patients) or total weekly Kt/V less than 1.7 (peritoneal dialysis patients) 10. Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy 11. Active haemolysis 12. Any surgery within the last 6 weeks 13. Infection within 6 weeks of the last dose of antibiotic, acute myocardial infarction or malignancy within the last 6 weeks 14. Melatonin treatment, androgen therapy or blood transfusion within the previous 4 weeks 15. Vitamin C therapy at dose greater than 1000mg/day or at a dose which has changed within the last 12 weeks 16. Haemorrhagic stroke or severe haemorrhage within the last 12 weeks 17. Current immunosuppressant use, or immunosupression during previous 4 weeks
Outcome results
None listed