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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's hemoglobin (Hb) level.
Period Title: Overall Study
Started 70
Completed 29
Not Completed 41
Reason Not Completed
Adverse Event             3
Protocol Violation             16
Lost to Follow-up             21
Other             1
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Population: All participants who received at least 1 dose of methoxy polyethylene glycol-epoetin beta treatment and for whom at least 1 follow-up data was available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
45.80  (16.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
45
  64.3%
Male
25
  35.7%
1.Primary Outcome
Title Change From Baseline in Mean Hb Concentration at Week 20
Hide Description 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]).
Time Frame Baseline (Week 0), Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: Grams per deciliter (gm/dL)
Baseline (n=53) 8.820  (0.736)
Change at Week 20 (n=35) 1.440  (1.144)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methoxy Polyethylene Glycol-Epoetin Beta
Comments Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Mean Hb Concentration at Week 24
Hide Description 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]).
Time Frame Baseline (Week 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: gm/dL
1.470  (1.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methoxy Polyethylene Glycol-Epoetin Beta
Comments Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Mean Hb Concentration at Week 28
Hide Description 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]).
Time Frame Baseline (Week 0), Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: gm/dL
1.680  (1.115)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methoxy Polyethylene Glycol-Epoetin Beta
Comments Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Time Frame From screening up to 32 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
All-Cause Mortality
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   7/70 (10.00%) 
Infections and infestations   
Pneumonia cytomegaloviral * 1  1/70 (1.43%) 
Injury, poisoning and procedural complications   
Complications of transplanted kidney * 1  1/70 (1.43%) 
Investigations   
Hemoglobin decreased * 1  1/70 (1.43%) 
Metabolism and nutrition disorders   
Hypocalcemia * 1  1/70 (1.43%) 
Renal and urinary disorders   
Renal failure chronic * 1  1/70 (1.43%) 
Renal failure * 1  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory failure * 1  1/70 (1.43%) 
Vascular disorders   
Peripheral ischemia * 1  1/70 (1.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   7/70 (10.00%) 
Infections and infestations   
Urinary tract infection * 1  7/70 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01342640    
Other Study ID Numbers: ML25300
First Submitted: April 20, 2011
First Posted: April 27, 2011
Results First Submitted: September 28, 2015
Results First Posted: October 26, 2015
Last Update Posted: July 12, 2017