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An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

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: NCT02547454
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : November 23, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Kidney Disease, Chronic
Intervention Drug: Methoxy polyethylene glycol-epoetin beta
Enrollment 393
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
Period Title: Overall Study
Started 393
Completed 221
Not Completed 172
Reason Not Completed
Due to hemodialysis             53
Due to transplantation             1
Due to no further need to treat             4
Death             38
Lost to Follow-up             26
Other             39
No data             11
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Baseline Participants 393
Hide Baseline Analysis Population Description
Analysis population included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 393 participants
73  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 393 participants
Female
216
  55.0%
Male
177
  45.0%
1.Primary Outcome
Title Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 390
Measure Type: Number
Unit of Measure: Percentage of participants
22.8
2.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: Percentage of participants
34
3.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 4-6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 296
Measure Type: Number
Unit of Measure: Percentage of participants
35.1
4.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 7-9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: Percentage of participants
32.3
5.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 10-12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: Percentage of participants
35.2
6.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 13-15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 170
Measure Type: Number
Unit of Measure: Percentage of participants
33.5
7.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 16-18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentage of participants
31.4
8.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 19-21
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: Percentage of participants
26
9.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame After 21 Months up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
31.4
10.Primary Outcome
Title Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 390
Measure Type: Number
Unit of Measure: Percentage of participants
71.3
11.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: Percentage of participants
77.2
12.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 4-6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 296
Measure Type: Number
Unit of Measure: Percentage of participants
73.6
13.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 7-9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: Percentage of participants
74.1
14.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 10-12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: Percentage of participants
75.9
15.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 13-15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 170
Measure Type: Number
Unit of Measure: Percentage of participants
78.2
16.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 16-18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentage of participants
79.7
17.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame At Months 19-21
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: Percentage of participants
75
18.Primary Outcome
Title Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
Hide Description If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Time Frame After 21 Months up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
68.6
19.Secondary Outcome
Title Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
Hide Description [Not Specified]
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 390
Median (Full Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median time (full range) to obtain Hb value within the target range was not possible to analyze due to fluctuation within and outside of range.
20.Secondary Outcome
Title Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
Hide Description [Not Specified]
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Median (Full Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median time (full range) to obtain Hb value within the target range was not analyzed due to fluctuation within and outside of range.
21.Secondary Outcome
Title Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Hide Description Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Mean (Standard Deviation)
Unit of Measure: microgram
88  (46)
22.Secondary Outcome
Title Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Hide Description Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.
Time Frame Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants. Here, n signifies participants with available data at specified time-point.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Median (Full Range)
Unit of Measure: microgram
Month 1 (n=393)
100
(50 to 400)
Month 3 (n=263)
75
(50 to 480)
Month 6 (n=300)
75
(30 to 300)
Month 9 (n=239)
67
(30 to 400)
Month 12 (n=206)
50
(25 to 360)
Month 15 (n=175)
50
(30 to 360)
Month 18 (n=177)
50
(30 to 250)
Month 21 (n=93)
50
(0 to 300)
After 21 Months up to 36 Months (n=30)
50
(30 to 250)
23.Secondary Outcome
Title Number of Dose Adaptations
Hide Description Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Measure Type: Number
Unit of Measure: Events
Total dose adaptations 729
Inflammation or infection 11
Kidney function decline 32
Over response 314
Iron deficiency 14
Insufficient response 213
Adverse effect 2
Start of maintenance phase 71
Kidney function improvement 4
Re-introduction of treatment 41
Other 27
24.Secondary Outcome
Title Percentage of Participants With Dose 0
Hide Description Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Measure Type: Number
Unit of Measure: Percentage of participants
32.6
25.Secondary Outcome
Title Percentage of Participants With Iron Replacement
Hide Description Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled participants.
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
Overall Number of Participants Analyzed 393
Measure Type: Number
Unit of Measure: Percentage of participants
Oral Iron Replacement 37.7
Intravenous Iron Replacment 31.6
Oral and Intravenous Iron Replacment 10.9
No Iron Replacment 19.8
Time Frame Up to 36 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
All-Cause Mortality
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   3/393 (0.76%) 
Cardiac disorders   
Orthostatic collapse * 1  1/393 (0.25%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/393 (0.25%) 
Epileptic seizure * 1  1/393 (0.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%)
Total   2/393 (0.51%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/393 (0.25%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/393 (0.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02547454     History of Changes
Other Study ID Numbers: ML22069
First Submitted: September 9, 2015
First Posted: September 11, 2015
Results First Submitted: October 21, 2015
Results First Posted: November 23, 2015
Last Update Posted: June 7, 2017