HERO Study - Handling Erythropoietin Resistance with Oxpentifylline

Phase 4

Completed

• Conditions: Erythropoietin-resistant anaemia; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12608000199314
• Lead Sponsor: Australasian Kidney Trials Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-14
• Study Completion: 2013-06-01
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified