A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576303
First received: December 18, 2007
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP [ Time Frame: EEP (Week 16 to Week 24) ] [ Designated as safety issue: No ]
    All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24


Secondary Outcome Measures:
  • Mean Change in Hb Concentration From Baseline to the EEP [ Time Frame: Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24) ] [ Designated as safety issue: No ]
    A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24

  • Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP [ Time Frame: EEP (Week 16 to Week 24) ] [ Designated as safety issue: No ]
    All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24

  • Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP [ Time Frame: EEP (Week 16 to Week 24) ] [ Designated as safety issue: No ]
    The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24

  • Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP [ Time Frame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44) ] [ Designated as safety issue: No ]
    The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44

  • Number of Participants With Red Blood Cell Transfusion [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The number of participants who underwent red blood cell transfusion was reported


Enrollment: 200
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO0503821 (C.E.R.A.), 1x/4weeks
Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv monthly (starting dose)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
  • continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B12 deficiency.
  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: NCT00576303

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620102
Kemerovo, Russian Federation, 650066
Krasnodar, Russian Federation, 350086
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 123182
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 127006
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 129317
Novosibirsk, Russian Federation, 630087
Omsk, Russian Federation, 644111
St Petersburg, Russian Federation, 191015
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 196247
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197110
St-Petersburg, Russian Federation, 198510
Volzhsky, Russian Federation, 404130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576303     History of Changes
Other Study ID Numbers: ML20977 
Study First Received: December 18, 2007
Results First Received: April 20, 2016
Last Updated: April 20, 2016
Health Authority: Russia: Federal Agency of Drug Quality Control

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on August 25, 2016