Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01342640
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : October 26, 2015
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 20, 2011
First Posted Date  ICMJE April 27, 2011
Results First Submitted Date  ICMJE September 28, 2015
Results First Posted Date  ICMJE October 26, 2015
Last Update Posted Date July 12, 2017
Actual Study Start Date  ICMJE July 18, 2011
Actual Primary Completion Date November 30, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Change From Baseline in Mean Hb Concentration at Week 20 [ Time Frame: Baseline (Week 0), Week 20 ]
    Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
  • Change From Baseline in Mean Hb Concentration at Week 24 [ Time Frame: Baseline (Week 0), Week 24 ]
    PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
  • Change From Baseline in Mean Hb Concentration at Week 28 [ Time Frame: Baseline (Week 0), Week 28 ]
    PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
Change in hemoglobin concentration [ Time Frame: Week 28 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
Safety: Incidence of adverse events [ Time Frame: 32 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Official Title  ICMJE A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA
Brief Summary This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
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]
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
Study Arms  ICMJE Experimental: Single Arm
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: September 28, 2015)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2011)
90
Actual Study Completion Date  ICMJE November 30, 2012
Actual Primary Completion Date November 30, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Diagnosis of chronic renal anemia
  • Not on dialysis
  • Hemoglobin concentration <10 g/dl
  • No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
  • Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
  • Adequate iron status

Exclusion Criteria:

  • Transfusion of red blood cells during the previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
  • Active malignant disease (except non-melanoma skin cancer)
  • Hemolysis
  • Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
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 Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01342640
Other Study ID Numbers  ICMJE ML25300
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 June 2017

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