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Sponsored by: |
Romanian Society of Nephrology |
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Information provided by: | Romanian Society of Nephrology |
ClinicalTrials.gov Identifier: | NCT00349960 |
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 dialyzed patients Bioequivalence of once-every-two-weeks and once-weekly subcutaneous administration of the same total dose of epoetin beta for the maintenance phase of anemia treatment in stable, iron-replete, chronic hemodialyzed patients was therefore prospectively investigated.
two treatment schedules will be considered equivalent if the primary efficacy parameters will be simultaneously similar for both groups and in the predefined range of variation. Confidence intervals (CIs) will be used to compare groups. Since the target Hb in dialyzed patients is defined as 11g/dL (110 g/L) by the European Guidelines and as >10 g/dL (100 g/L) by the National Guidelines, with a recommended upper limit of 13 g/dL (130 g/L), the efficacy range for Hb in this study was predefined as 10-12 g/dL (100-120 g/L). The two treatment schedules will be considered to have similar efficacy if the mean Hb in Group 2w will not differ by more than ±0.5 g/dL (±5 g/L) compared to Group 1w during the assessment period. Once similar efficacy established, drug requirements will be compared calculating the ratio of the mean weekly epoetin doses in Group 2w/Group 1w. A range of 0.8 to 1.25 for the ratio is considered sufficient to define bioequivalence. Equivalence of drug usage in the two arms will be accepted if the whole 95% CI for this ratio will be within the above limits.
Lack of difference between group means does not imply similar distribution of treatment effects within each group. The individual hemoglobin change will be used to assess if response to treatment was similarly variable in the two arms. The change in Hb will be calculated for each patient as the difference between the mean Hb during the assessment period and the mean Hb during the baseline phase.
Condition | Intervention |
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Hemodialyzed Patients Epoetin Treatment |
Drug: NeoRecormon SC once-weekly versus once-every-other-week |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
Official Title: | Once-Weekly Versus Once-Fortnightly Subcutaneous Epoetin Beta Administration in the Maintenance Phase of Anaemia Treatment in Haemodialyzed Patients |
Estimated Enrollment: | 200 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Romania | |
"Dr Carol Davila" Teaching Hospital of Nephrology | |
Bucharest, Romania, 010731 | |
Dialysis and Transplantation Center, “CI Parhon” University Hospital | |
Iaşi, Romania | |
“Sf. Ioan Nou” Clinical Hospital, Nephrology and Dialysis Department | |
Bucharest, Romania | |
Dialysis and Renal Transplantation Centre, Timisoara County Hospital | |
Timisoara, Romania | |
Dialysis Centre, Army Medical Diagnosis and Treatment Centre | |
Bucharest, Romania | |
Dialysis Centre, “Fundeni” Clinical Institute, Bucharest | |
Bucharest, Romania | |
Nephrology and Dialysis Clinic, Craiova Clinical County Hospital | |
Craiova, Romania | |
Nephrology and Dialysis Department, Dâmboviţa County Hospital | |
Targoviste, Romania | |
Nephrology and Dialysis Clinic, Cluj Clinical County Hospital | |
Cluj Napoca, Romania |
Study Director: | Gabriel Mircescu Mircescu, Professor | Romanian Society of Nephrology |
Study ID Numbers: | 3025 |
Study First Received: | July 6, 2006 |
Last Updated: | July 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00349960 |
Health Authority: | Romania: National Medicines Agency |
Erythropoiesis stimulating agent Dosing frequency Hemodialysis Therapeutic equivalence |
Epoetin Alfa Anemia |