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A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

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ClinicalTrials.gov Identifier: NCT00922116
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : December 9, 2015
Last Update Posted : July 13, 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 191
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mircera
Hide Arm/Group Description Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Period Title: Overall Study
Started 191
Completed 176
Not Completed 15
Reason Not Completed
Adverse Event             4
Death             1
Lost to Follow-up             1
Withdrawal by Subject             4
Other             5
Arm/Group Title Mircera
Hide Arm/Group Description Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Baseline Participants 191
Hide Baseline Analysis Population Description
Safety population defined as all participants who participated in the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants
60.4  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants
Female
114
  59.7%
Male
77
  40.3%
1.Primary Outcome
Title Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
Hide Description The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Time Frame EEP (Weeks 17 to 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 187
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.9
(46.3 to 61.4)
2.Secondary Outcome
Title Change in Hemoglobin Concentration Between SVP and the EEP
Hide Description Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Time Frame SVP (Baseline), and EEP (Weeks 17 to 24)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 187
Mean (Standard Deviation)
Unit of Measure: grams per deciliter (g/dL)
0.55  (0.93)
3.Secondary Outcome
Title Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
Hide Description EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Time Frame EEP (Weeks 17 to 24)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 187
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.0
(65.9 to 79.4)
4.Secondary Outcome
Title Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
Hide Description DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Frame Weeks 1 to 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 187
Measure Type: Number
Unit of Measure: percentage of participants
87.2
5.Secondary Outcome
Title Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
Hide Description DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Frame Weeks 1 to 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 158
Mean (Standard Deviation)
Unit of Measure: days
103.6  (41.9)
6.Secondary Outcome
Title Average Dose of Mircera Per Month
Hide Description [Not Specified]
Time Frame Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
Arm/Group Title Mircera
Hide Arm/Group Description:
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
Overall Number of Participants Analyzed 145
Mean (Standard Deviation)
Unit of Measure: microgram (mcg)
Week 0-4 121.2  (9.8)
Week 4-8 100.8  (33.3)
Week 8-12 78.8  (45.8)
Week 12-16 72.7  (46.6)
Week 16-20 66.9  (48.0)
Week 20-24 66.2  (47.1)
Time Frame up to Week 28
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mircera
Hide Arm/Group Description Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
All-Cause Mortality
Mircera
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Mircera
Affected / at Risk (%)
Total   31/191 (16.23%) 
Cardiac disorders   
Ischaemic cardiomyopathy * 1  1/191 (0.52%) 
Ventricular extrasystoles * 1  1/191 (0.52%) 
Eye disorders   
Glaucoma * 1  1/191 (0.52%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/191 (0.52%) 
General disorders   
Asthenia * 1  1/191 (0.52%) 
Fatigue * 1  1/191 (0.52%) 
Generalised oedema * 1  1/191 (0.52%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  1/191 (0.52%) 
Cholelithiasis * 1  1/191 (0.52%) 
Infections and infestations   
Appendicitis * 1  1/191 (0.52%) 
Cellulitis * 1  1/191 (0.52%) 
Herpes zoster * 1  1/191 (0.52%) 
Pneumonia * 1  1/191 (0.52%) 
Sepsis * 1  1/191 (0.52%) 
Upper respiratory tract infection * 1  1/191 (0.52%) 
Wound infection * 1  1/191 (0.52%) 
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  1/191 (0.52%) 
Metabolism and nutrition disorders   
Gout * 1  1/191 (0.52%) 
Musculoskeletal and connective tissue disorders   
Flank pain * 1  1/191 (0.52%) 
Rhabdomyolysis * 1  1/191 (0.52%) 
Nervous system disorders   
Dizziness * 1  2/191 (1.05%) 
Renal and urinary disorders   
Azotaemia * 1  1/191 (0.52%) 
Calculus ureteric * 1  1/191 (0.52%) 
Diabetic nephropathy * 1  1/191 (0.52%) 
Renal failure chronic * 1  12/191 (6.28%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/191 (0.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mircera
Affected / at Risk (%)
Total   90/191 (47.12%) 
General disorders   
Oedema * 1  16/191 (8.38%) 
Infections and infestations   
Nasopharyngitis * 1  17/191 (8.90%) 
Upper respiratory tract infection * 1  20/191 (10.47%) 
Metabolism and nutrition disorders   
Hyperkalaemia * 1  12/191 (6.28%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  10/191 (5.24%) 
Vascular disorders   
Hypertension * 1  15/191 (7.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: NCT00922116    
Other Study ID Numbers: ML22285
First Submitted: June 16, 2009
First Posted: June 17, 2009
Results First Submitted: November 4, 2015
Results First Posted: December 9, 2015
Last Update Posted: July 13, 2017