A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737711
First received: August 18, 2008
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. 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 4

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 Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period [ Time Frame: Baseline (Week 0) and Week 16 ] [ Designated as safety issue: No ]
    The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.


Secondary Outcome Measures:
  • Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.

  • Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 [ Time Frame: Week 12 to Week 16 ] [ Designated as safety issue: No ]
    The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.

  • Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 [ Time Frame: Week 12 to Week 16 ] [ Designated as safety issue: No ]
    The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.

  • Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: Up to Week 18 ] [ Designated as safety issue: No ]
    An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above

  • Number of Participants With Abnormal Electrocardiogram [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.

  • Number of Participants With Reports of Blood Transfusions [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.

  • Number of Participants With Reports of Anti-Epoetin Antibodies [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.

  • Mean White Blood Cell Count Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Value of Mean Corpuscular Volume Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.

  • Mean Hypochromic Red Blood Cells Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Platelet Count Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Iron Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Ferritin Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Transferrin Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Total Iron-binding Capacity Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Transferrin Saturation Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.

  • Mean Serum Albumin Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Globulin Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Creatinine Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Blood Urea Nitrogen Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Potassium Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Sodium Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Phosphate Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Bilirubin Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Aspartate Transaminase Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Alanine Aminotransferase Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  • Mean Serum Alkaline Phosphatase Over Time [ Time Frame: Baseline (Week 0), Week 4, Week 10, and Week 16 ] [ Designated as safety issue: No ]
    Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.


Enrollment: 189
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv 0.6 micrograms/kg every 2 weeks

  Eligibility

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

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
  • no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

  • blood transfusion within the previous 4 weeks;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
  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: NCT00737711

Locations
India
Ahmedabad, India, 380007
Bangalore, India, 560034
Chennai, India, 603103
Coimbatore, India, 641004
Gujarat, India, 387 001
Hyderabad, India, 500001
Kerala, India, 682017
Kolkata, India, 700099
Ludhiana, India
Mumbai, India, 400026
Mumbai, India
New Delhi, India, 110 060
New Delhi, India, 110017
New Delhi, India, 110026
Vellore, India, 632 004
Vishakpatnam, India, 530002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737711     History of Changes
Other Study ID Numbers: ML21822 
Study First Received: August 18, 2008
Results First Received: March 8, 2016
Last Updated: April 26, 2016
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on August 28, 2016