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A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

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ClinicalTrials.gov Identifier: NCT00737464
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : April 29, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 18, 2008
First Posted Date  ICMJE August 19, 2008
Results First Submitted Date  ICMJE February 25, 2016
Results First Posted Date  ICMJE April 29, 2016
Last Update Posted Date December 7, 2017
Actual Study Start Date  ICMJE August 26, 2008
Actual Primary Completion Date September 12, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) [ Time Frame: Weeks 8 to 12 (Last 4 weeks of treatment period) ]
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Proportion of patients maintaining Hb levels within the target range during the last 4 weeks of the treatment period. [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12) [ Time Frame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12) ]
    The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
  • Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL [ Time Frame: Up to Week 12 ]
    Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.
  • Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths [ Time Frame: Up to Week 14 ]
    Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. 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.
  • Mean Change From Baseline in Heart Rate Over Time [ Time Frame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12 ]
    Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
  • Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time [ Time Frame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12 ]
    Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
  • Number of Participants With Abnormal Electrocardiogram [ Time Frame: At Week -2 and Week 12 ]
    Participants with abnormal electrocardiogram were reported.
  • Mean Values of White Blood Cells and Platelets Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
  • Mean Values of Hypochromic Red Blood Cells Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
  • Mean Corpuscular Volume Levels Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
  • Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of serum iron and total iron binding capacity (TIBC) were reported.
  • Mean Values of Serum Ferritin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of serum ferritin were reported.
  • Mean Values of Transferrin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of transferrin were reported.
  • Mean Values of Transferrin Saturation Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of Transferrin Saturation (TSAT) were reported.
  • Mean Values of Serum Albumin and Serum Globulin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of serum albumin and serum globulin were reported.
  • Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
  • Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
  • Mean Values of Serum Sodium and Serum Potassium Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ]
    Mean values of serum sodium and serum potassium were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
  • Change in mean Hb concentration between reference and the last 4 weeks of the treatment period; mean time spent in Hb range 10.0g/dL - 12.0g/dL. [ Time Frame: Week 12 ]
  • Incidence of adverse events, serious adverse events and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Official Title  ICMJE A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Brief Summary This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Study Arms  ICMJE Experimental: Mircera
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2013)
132
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2008)
170
Actual Study Completion Date  ICMJE September 12, 2009
Actual Primary Completion Date September 12, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia;
  • Hb concentration 10.5g/dL - 12.5g/dL;
  • continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

  • blood transfusion within the previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00737464
Other Study ID Numbers  ICMJE ML21810
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2017

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