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A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576628
First received: December 18, 2007
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). 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 [C.E.R.A.]
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period [ Time Frame: Baseline (Week 0) and from Week 29 to Week 36 ]
    The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.


Secondary Outcome Measures:
  • Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP [ Time Frame: From Week 29 to Week 36 ]
    Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.

  • Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period [ Time Frame: From Week 29 to Week 36 ]
    The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.

  • The Number of Participants Who Required Dose Adjustments During the Dose Titration Period [ Time Frame: From Week 0 to Week 28 (DTP) ]
    The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

  • Time to Achievement of Response During the Efficacy Evaluation Period [ Time Frame: From Week 29 to Week 36 ]
    The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.

  • Number of Participants With Red Blood Cells Transfusions. [ Time Frame: Up to Week 52 ]
    The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.

  • Mean Values of Laboratory Parameter : Hb Concentration [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameter : Hematocrit [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameter : Serum Creatinine [ Time Frame: Baseline (Week 0), and Week 32 ]
    The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.

  • Mean Values of Laboratory Parameter: C Reactive Protein [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameter: Ferritin Concentration [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • Mean Values of Laboratory Parameters: Transferrin Saturation [ Time Frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 ]
    The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  • The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period [ Time Frame: From Week 29 to Week 36 (EEP) ]
    The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.


Enrollment: 133
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C.E.R.A
Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Recommended starting dose 1.2 micrograms/kg sc monthly

  Eligibility

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia, with no need for dialysis expected in next 3 months;
  • adequate iron status.

Exclusion Criteria:

  • previous epoetin therapy within 12 weeks prior to treatment;
  • transfusion of red blood cells during 2 months prior to screening;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B 12 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: NCT00576628

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664079
Khanty-Mansiysk, Russian Federation, 628011
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 123182
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 129110
Nizhny Novgorod, Russian Federation, 603001
Nizhny Novgorod, Russian Federation, 603126
Omsk, Russian Federation, 644112
Orenburg, Russian Federation, 460018
Rostov-na-donu, Russian Federation, 344029
Saratov, Russian Federation, 410053
St Petersburg, Russian Federation, 194354
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197110
Tjumen, Russian Federation, 625023
UFA, Russian Federation, 450005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576628     History of Changes
Other Study ID Numbers: ML20978
Study First Received: December 18, 2007
Results First Received: July 21, 2016
Last Updated: October 7, 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on March 24, 2017