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A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560404
First received: November 16, 2007
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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]
Drug: Epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability 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 Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period [ Time Frame: EEP (Week 29 to Week 36) ] [ Designated as safety issue: No ]
    The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.


Secondary Outcome Measures:
  • Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period [ Time Frame: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36) ] [ Designated as safety issue: No ]
    The Baseline (Safety Verification Period) was from Week - 4 to Week -1.

  • Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period [ Time Frame: EEP (Weeks 29 to 36) ] [ Designated as safety issue: No ]
    Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.

  • Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period [ Time Frame: EEP (Week 29 to Week 36) ] [ Designated as safety issue: No ]
    Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.

  • Number of Participants Who Required Dose Adjustments During the Dose Titration Period [ Time Frame: DTP (Weeks 0 to 28) ] [ Designated as safety issue: No ]
    The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

  • Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period [ Time Frame: EEP (Weeks 29 to 36) ] [ Designated as safety issue: No ]
    The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.

  • Number of Participants Received Red Blood Cells Transfusions [ Time Frame: Up to Week 28 ] [ Designated as safety issue: No ]
    The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.

  • Mean Values of Hemoglobin Concentration at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.

  • Mean Values of Hematocrit at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.

  • Mean Values of Mean Corpuscular Volume at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.

  • Mean Values of Leukocytes and Platelets Count at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.

  • Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.

  • Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.

  • Mean Values of Ferritin Concentration at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.

  • Mean Values of Transferrin Saturation at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.

  • Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 40 ] [ Designated as safety issue: No ]
    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. 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. Number of participants with at least one AE and SAE were reported.

  • Number of Participants With Abnormal Changes in ECG From Baseline to Week 40 [ Time Frame: From Baseline to Week 40 ] [ Designated as safety issue: No ]
    Twelve-lead ECG was performed.

  • Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40 [ Time Frame: From Baseline to Week 40 ] [ Designated as safety issue: No ]
    Vital signs included blood pressure, pulse rate and body weight.


Enrollment: 233
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc monthly (starting dose)
Active Comparator: 2 Drug: Epoetin alfa
As prescribed

  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;
  • regular hemodialysis with the same schedule of dialysis for >=12 weeks;
  • maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
  • acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).
  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: NCT00560404

Locations
Brazil
Belo Horizonte, Brazil, 30150-320
Brasilia, Brazil, 70390-108
Campinas, Brazil, 13086-970
Campo Grande, Brazil, 79002-073
Cariacica, Brazil, 29152-230
Curitiba, Brazil, 80050-350
Curitiba, Brazil, 80440-020
Fortaleza, Brazil, 60430160
Jaboatão Dos Guararapes, Brazil, 54400-170
Joinville, Brazil, 89227-680
Juiz de Fora, Brazil, 36036900
Londrina, Brazil, 86015-000
Natal, Brazil, 59020-110
Porto Alegre, Brazil, 90035-903
Porto Alegre, Brazil, 90610000
Ribeirão Preto, Brazil, 14025-170
Rio de Janeiro, Brazil
Salvador, Brazil, 40110-060
Sao Jose Do Rio Preto, Brazil, 15090-000
Sao Luis, Brazil, 65020-305
Sao Paulo, Brazil, 01246-903
Sao Paulo, Brazil, 01323-900
Sao Paulo, Brazil, 01532-001
Sao Paulo, Brazil, 03065-000
Sao Paulo, Brazil, O4023
Sorocaba, Brazil, 18030-210
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560404     History of Changes
Other Study ID Numbers: ML21208 
Study First Received: November 16, 2007
Results First Received: January 19, 2016
Last Updated: March 14, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on September 27, 2016