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Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

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ClinicalTrials.gov Identifier: NCT00517881
Recruitment Status : Terminated (The study was terminated due to the slow recruitment rate.)
First Posted : August 17, 2007
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Enrollment 29

Recruitment Details  
Pre-assignment Details  
Arm/Group Title C.E.R.A.
Hide Arm/Group Description Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Period Title: Overall Study
Started 29
Completed 24
Not Completed 5
Reason Not Completed
Protocol Violation             2
Adverse Event             1
Renal transplantation             2
Arm/Group Title C.E.R.A.
Hide Arm/Group Description Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
The safety population included all participants who were treated with at least 1 dose of the study drug and a safety follow-up, whether withdrawn prematurely or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
60.6  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
18
  62.1%
Male
11
  37.9%
1.Primary Outcome
Title Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
Hide Description Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
Time Frame Week 17 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.7
(32.5 to 70.6)
2.Secondary Outcome
Title Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Hide Description The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
Time Frame Week 17 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population; data missing at the end of the EEP was handled using the last value carried forward method.
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.3  (1.04)
3.Secondary Outcome
Title Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Hide Description Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
Time Frame Week 17 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population; data missing at the end of the EEP was handled using the last value carried forward method.
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.6
(38.9 to 76.5)
4.Secondary Outcome
Title Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Hide Description Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
Time Frame Week 17 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: days
31  (17.2)
5.Secondary Outcome
Title Percentage of Participants Requiring Any Dose Adjustment
Hide Description Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Time Frame Week 1 up to Week 16 and Week 17 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Here, 'n' signifies the number of participants evaluable for specified category.
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
DTP (n = 29) 62
EEP (n = 26) 31
6.Secondary Outcome
Title Percentage of Participants With Red Blood Cell Transfusion During the Study
Hide Description Percentage of participant who required red blood cell transfusion during the study was reported.
Time Frame Week 0 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
7
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Time Frame Week 0 up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title C.E.R.A.
Hide Arm/Group Description:
Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
AEs 22
SAEs 9
Time Frame Week 0 up to Week 24
Adverse Event Reporting Description Only adverse events with an onset date after the start of medication were included.
 
Arm/Group Title C.E.R.A.
Hide Arm/Group Description Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
All-Cause Mortality
C.E.R.A.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
C.E.R.A.
Affected / at Risk (%)
Total   9/29 (31.03%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/29 (3.45%) 
Cardiac disorders   
Atrial fibrillation * 1  1/29 (3.45%) 
General disorders   
Oedema * 1  1/29 (3.45%) 
Oedema peripheral * 1  1/29 (3.45%) 
Infections and infestations   
Diabetic foot infection * 1  1/29 (3.45%) 
Pneumonia * 1  1/29 (3.45%) 
Wound infection * 1  1/29 (3.45%) 
Injury, poisoning and procedural complications   
Arteriovenous fistula thrombosis * 1  1/29 (3.45%) 
Renal and urinary disorders   
Renal impairment * 1  1/29 (3.45%) 
Surgical and medical procedures   
Dialysis device insertion * 1  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
C.E.R.A.
Affected / at Risk (%)
Total   10/29 (34.48%) 
Gastrointestinal disorders   
Nausea * 1  3/29 (10.34%) 
General disorders   
Fatigue * 1  3/29 (10.34%) 
Infections and infestations   
Nasopharyngitis * 1  2/29 (6.90%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/29 (6.90%) 
Nervous system disorders   
Dizziness * 1  3/29 (10.34%) 
Headache * 1  2/29 (6.90%) 
Vascular disorders   
Hypotension * 1  2/29 (6.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
The study was terminated early due to the slow recruitment rate.
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: NCT00517881     History of Changes
Other Study ID Numbers: ML20944
2006-006523-40 ( EudraCT Number )
First Submitted: August 16, 2007
First Posted: August 17, 2007
Results First Submitted: April 21, 2016
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016