Epoetin Dosing Regimens in Haemodialysis

This study has been completed.
Sponsor:
Information provided by:
Romanian Society of Nephrology
ClinicalTrials.gov Identifier:
NCT00349960
First received: July 6, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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
Hemodialyzed Patients
Epoetin Treatment
Drug: NeoRecormon SC once-weekly versus once-every-other-week

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Once-Weekly Versus Once-Fortnightly Subcutaneous Epoetin Beta Administration in the Maintenance Phase of Anaemia Treatment in Haemodialyzed Patients

Resource links provided by NLM:


Further study details as provided by Romanian Society of Nephrology:

Primary Outcome Measures:
  • hemoglobin level in the assessment period (average of all values from weeks 13-24)
  • weekly epoetin beta dose per dry body weight in the assessment period (average of all values from weeks 13-24)

Secondary Outcome Measures:
  • the percentage of patients maintaining target Hb without any increase in epoetin dose during the assessment period;
  • the difference between the average Hb levels during the assessment period versus the baseline phase;
  • the difference between the average weekly epoetin beta dose during the assessment period versus the baseline phase.

Estimated Enrollment: 200
Study Start Date: March 2004
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349960

Locations
Romania
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731
Dialysis Centre, “Fundeni” Clinical Institute, Bucharest
Bucharest, Romania
“Sf. Ioan Nou” Clinical Hospital, Nephrology and Dialysis Department
Bucharest, Romania
Dialysis Centre, Army Medical Diagnosis and Treatment Centre
Bucharest, Romania
Nephrology and Dialysis Clinic, Cluj Clinical County Hospital
Cluj Napoca, Romania
Nephrology and Dialysis Clinic, Craiova Clinical County Hospital
Craiova, Romania
Dialysis and Transplantation Center, “CI Parhon” University Hospital
Iaşi, Romania
Nephrology and Dialysis Department, Dâmboviţa County Hospital
Targoviste, Romania
Dialysis and Renal Transplantation Centre, Timisoara County Hospital
Timisoara, Romania
Sponsors and Collaborators
Romanian Society of Nephrology
Investigators
Study Director: Gabriel Mircescu Mircescu, Professor Romanian Society of Nephrology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00349960     History of Changes
Other Study ID Numbers: 3025
Study First Received: July 6, 2006
Last Updated: July 6, 2006
Health Authority: Romania: National Medicines Agency

Keywords provided by Romanian Society of Nephrology:
Erythropoiesis stimulating agent
Dosing frequency
Hemodialysis
Therapeutic equivalence

Additional relevant MeSH terms:
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014