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

August 18, 2008
April 26, 2016
July 2008
October 2009   (final data collection date for primary outcome measure)
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.
Mean change in Hb concentration from baseline to last visit [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737711 on ClinicalTrials.gov Archive Site
  • 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.
  • Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
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).
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv 0.6 micrograms/kg every 2 weeks
Experimental: Mircera
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
October 2009
October 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00737711
ML21822
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP