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A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661388
First received: April 16, 2008
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended 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 [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 Study to Assess the Efficacy, Safety and Tolerability of Once-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 Between Baseline and the Efficacy Evaluation Period [ Time Frame: From Baseline (Week 0) to EEP (Week 29 to Week 36) ] [ Designated as safety issue: No ]
    Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.


Secondary Outcome Measures:
  • Mean Time to Achievement of Response During the EEP [ Time Frame: From Week 29 to Week 36 ] [ Designated as safety issue: No ]
    Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.

  • The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP [ Time Frame: From Week 29 to Week 36 ] [ Designated as safety issue: No ]
    The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.

  • Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP [ Time Frame: From Week 29 to Week 36 ] [ Designated as safety issue: No ]
    Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.

  • Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP [ Time Frame: Weeks 0 to Week 36 ] [ Designated as safety issue: No ]
    Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

  • Number of Participants Who Received Red Blood Cell Transfusions During the Study Period [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.

  • Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

  • Mean Change From Baseline in Hb Concentration Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Hematocrit Level Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Albumin Concentration Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in C-Reactive Protein Concentration Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Creatinine Concentration Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 32, 40 ] [ Designated as safety issue: No ]
    Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Ferritin Concentration Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Transferrin Saturation Over Time [ Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.


Enrollment: 75
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous erythropoietin receptor activator (C.E.R.A.)
Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)

  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;
  • predialysis stage;
  • no ESA therapy during previous 3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization in previous 6 months;
  • significant acute or chronic bleeding.
  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: NCT00661388

Locations
Turkey
Ankara, Turkey, 06100
Denizli, Turkey, 20100
Edirne, Turkey, 22030
Istanbul, Turkey, 34000
Istanbul, Turkey, 34377
Istanbul, Turkey, 34381
Istanbul, Turkey, 34390
Kahramanmaras, Turkey, 46100
Konya, Turkey, 42770
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661388     History of Changes
Other Study ID Numbers: ML21524 
Study First Received: April 16, 2008
Results First Received: June 9, 2016
Last Updated: July 28, 2016
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 23, 2016