Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia (NCT NCT01677767)

NCT ID: NCT01677767

Last Updated: 2017-07-05

Results Overview

Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25

• Recruitment status: COMPLETED
• Target enrollment: 127 participants
• Primary outcome timeframe: Baseline (Week 0)
• Results posted on: 2017-07-05

Participant Flow

A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.

Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.

Participant milestones

Measure	C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Overall Study STARTED	124
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Overall Study Adverse Event	1
Overall Study Death	4
Overall Study Protocol Violation	4
Overall Study Withdrawal by Subject	10
Overall Study Non-compliance by the participants	3

Baseline Characteristics

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

Baseline characteristics by cohort

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Age, Continuous	48.1 Years STANDARD_DEVIATION 12.26 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Height	157.83 Centimeters STANDARD_DEVIATION 10.056 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0)

Population: The safety population included all participants enrolled into the study.

Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25

Outcome measures

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Mean Age of Participants Treated With C.E.R.A	48.1 Years Standard Deviation 12.26

PRIMARY outcome

Timeframe: Baseline (Week 0)

Population: The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.

Weight of the participants was measured at the Baseline and summarized with descriptive statistics.

Outcome measures

Measure	C.E.R.A. n=119 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Mean Weight of Participants Treated With C.E.R.A	57.44 Kilograms Standard Deviation 13.269

PRIMARY outcome

Timeframe: Up to Week 24

Population: The safety population included all participants enrolled into the study.

Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.

Outcome measures

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Number of Participants With Co-morbidity Treated With C.E.R.A Comorbidity, vascular disorders	61 Number of participants
Number of Participants With Co-morbidity Treated With C.E.R.A Total comorbid participants	107 Number of participants
Number of Participants With Co-morbidity Treated With C.E.R.A Comorbidity, renal and urinary disorders	63 Number of participants
Number of Participants With Co-morbidity Treated With C.E.R.A Comorbidity, metabolism and nutrition disorders	46 Number of participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\<) 10 g/dL at enrollment.

The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1

Outcome measures

Measure	C.E.R.A. n=95 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Mean Time Required to Achieve Target Hemoglobin Range	11.66 Week Standard Deviation 5.652

PRIMARY outcome

Timeframe: Up to Week 24

Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\<) 10 g/dL at enrollment.

The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.

Outcome measures

Measure	C.E.R.A. n=95 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Percentage of Participants Achieved Target Range of Hemoglobin	74.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.

Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.

Outcome measures

Measure	C.E.R.A. n=25 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.	20 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.

For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.

Outcome measures

Measure	C.E.R.A. n=121 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study	83 Number of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.

Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.

Outcome measures

Measure	C.E.R.A. n=121 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Mean Time Spent by Participants in the Hb Target Range	13.54 Week Standard Deviation 6.143

SECONDARY outcome

Timeframe: Up to Week 24

Population: The safety population included all participants enrolled into the study

C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.

Outcome measures

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Evaluation of Route of Administration for C.E.R.A Intravenous administration	11 Number of injections
Evaluation of Route of Administration for C.E.R.A Subcutaneous administration	647 Number of injections

SECONDARY outcome

Timeframe: Up to Week 24

Population: The safety population included all participants enrolled into the study

The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.

Outcome measures

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Evaluation of Dose Per Injection of C.E.R.A	64.0 Microgram Standard Deviation 21.30

SECONDARY outcome

Timeframe: Up to Week 24

Population: The safety population included all participants enrolled into the study

Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.

Outcome measures

Measure	C.E.R.A. n=124 Participants Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Number of Participants Received Concomitant Medications	122 Number of participants

Adverse Events

C.E.R.A.

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	C.E.R.A. n=124 participants at risk Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Gastrointestinal disorders Peritonitis	0.81% 1/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Asthenia	0.81% 1/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Death	1.6% 2/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Pneumonia	0.81% 1/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders Chronic renal failure	1.6% 2/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.81% 1/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Rash	0.81% 1/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Other adverse events

Measure	C.E.R.A. n=124 participants at risk Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
Gastrointestinal disorders Peritonitis	2.4% 3/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Vomiting	3.2% 4/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Chills	3.2% 4/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders Pyrexia	5.6% 7/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 3/124 • Up to Week 24 An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER