Epoetin Dosing Regimens in Haemodialysis

NCT00349960 | Completed

• 1 other identifier: 3025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

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 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.

Conditions

Hemodialyzed Patients; Epoetin Treatment

Keywords

Erythropoiesis stimulating agent; Dosing frequency; Hemodialysis; Therapeutic equivalence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

NeoRecormon SC once-weekly versus once-every-other-week DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Romanian Society of Nephrology: lead

Study Sites (9)

"Dr Carol Davila" Teaching Hospital of Nephrology

Bucharest, 010731, Romania

Location

"Sf. Ioan Nou" Clinical Hospital, Nephrology and Dialysis Department

Bucharest, Romania

Location

Dialysis Centre, "Fundeni" Clinical Institute, Bucharest

Bucharest, Romania

Location

Dialysis Centre, Army Medical Diagnosis and Treatment Centre

Bucharest, Romania

Location

Nephrology and Dialysis Clinic, Cluj Clinical County Hospital

Cluj-Napoca, Romania

Location

Nephrology and Dialysis Clinic, Craiova Clinical County Hospital

Craiova, Romania

Location

Dialysis and Transplantation Center, "CI Parhon" University Hospital

Iași, Romania

Location

Nephrology and Dialysis Department, Dâmboviţa County Hospital

Târgovişte, Romania

Location

Dialysis and Renal Transplantation Centre, Timisoara County Hospital

Timișoara, Romania

Location

Study Officials

• Gabriel Mircescu Mircescu, Professor

  Romanian Society of Nephrology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 10, 2006
• Study Start: March 1, 2004
• Study Completion: December 1, 2005
• Last Updated: July 10, 2006

Record last verified: 2006-02

Locations

RO (9)