Status:
COMPLETED
Epoetin Dosing Regimens in Haemodialysis
Lead Sponsor:
Romanian Society of Nephrology
Conditions:
Hemodialyzed Patients
Epoetin Treatment
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Currently, less frequent than once weekly subcutaneous epoetin administration regimens were shown to be equally effective and safe as the once-weekly schedules in stable pre-dialyzed and peritoneal di...
Detailed Description
Current European Best Practice Guidelines and the KDOQI Committee in the USA recommend preferential subcutaneous (SC) twice- to thrice-weekly epoetin administration. SC route significantly reduces epo...
Eligibility Criteria
Inclusion
- adult age (≥18 years)
- at least 6 months on HD
- efficient HD (urea-equilibrated Kt/V \>1.2, Daugirdas II equation)
- haemoglobin (Hb) levels above the Romanian recommended target of 10g/dL and stable (difference between the maximum and minimum values at three subsequent determinations ≤1.5g/dL)
- treatment with once-weekly SC epoetin beta for at least 2 months prior to enrollment
- serum ferritin level 80-800 ng/mL
- transferrin saturation 20-50%
Exclusion
- poor blood pressure control (BP ≥140/90mmHg in spite of antihypertensive medication and fluid control by dialysis)
- cardiac failure or hepatic diseases (as defined by abnormal ALT and AST levels) or association of psychical disorders or other disturbances making the enrollment unacceptable, as judged by the physician
- hyperkalemia
- malnutrition (Subjective Global Assessment score B or C and/or serum albumin \<4g/dL)
- acute infection or HIV infection
- significant inflammation (CRP \>12 mg/L)
- severe hyperparathyroidism (iPTH \>800 ng/mL)
- history of gastrointestinal bleeding
- \> 5% variation in dry body weight in the last 6 months
- previously diagnosed folic acid and/or vitamin B12 deficiency
- neoplastic diseases
- other known causes of anaemia
- known hypersensibility to one of the administered drugs
- epilepsy
- pregnancy or lactation
- anti-viral treatment during the month preceding the inclusion
- immunosuppressive treatment or use of other medication known to influence erythropoiesis 4 weeks before the enrollment
- participation in another clinical trial 4 weeks prior to enrollment
- need for blood transfusions within 8 weeks prior to enrollment.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00349960
Start Date
March 1 2004
End Date
December 1 2005
Last Update
July 10 2006
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731
2
"Sf. Ioan Nou" Clinical Hospital, Nephrology and Dialysis Department
Bucharest, Romania
3
Dialysis Centre, "Fundeni" Clinical Institute, Bucharest
Bucharest, Romania
4
Dialysis Centre, Army Medical Diagnosis and Treatment Centre
Bucharest, Romania