Trial Outcomes & Findings for A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients. (NCT NCT00605345)

Last Updated: 2016-09-23

Results Overview

Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

71 participants

Primary outcome timeframe

Weeks 16-28

Results posted on

2016-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	CERA Treatment Once Monthly CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly Darbepoetin Alfa as prescribed
Overall Study STARTED	46	25
Overall Study COMPLETED	45	22
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CERA Treatment Once Monthly CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly Darbepoetin Alfa as prescribed
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	0	2

Baseline Characteristics

A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed	Total n=71 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 11.04 • n=5 Participants	56.7 years STANDARD_DEVIATION 10.49 • n=7 Participants	55.3 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	8 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Spain	46 participants n=5 Participants	25 participants n=7 Participants	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 16-28

Population: Analysis was performed in the per protocol (PP) population.

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=42 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=21 Participants Darbepoetin Alfa as prescribed
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range	64.29 percentage of participants Interval 48.03 to 78.45	57.14 percentage of participants Interval 34.02 to 78.18

SECONDARY outcome

Timeframe: Baseline to 28 weeks

Population: Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug.

Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)	0.08 g/dL Standard Deviation 0.85	0.05 g/dL Standard Deviation 1.06

SECONDARY outcome

Timeframe: Weeks 16-28

Population: Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)	71.7 percentage of participants	64.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16-28

Population: Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.

Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)	57.0 days Standard Deviation 23.98	50.5 days Standard Deviation 27.7

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: Analysis was performed on the safety population.

Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed
Percentage of Participants Needing Dose Adjustments Dose Titration Period	73.9 percentage of participants	56.0 percentage of participants
Percentage of Participants Needing Dose Adjustments Efficacy Evaluation Period (n=45,23)	33.3 percentage of participants	20.8 percentage of participants

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.

Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

Outcome measures

Outcome measures
Measure	CERA Treatment Once Monthly n=46 Participants CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 Participants Darbepoetin Alfa as prescribed
Incidence of RBC Transfusions	1 participants	2 participants

Adverse Events

CERA Treatment Once Monthly

Serious events: 9 serious events

Other events: 27 other events

Deaths: 0 deaths

Darbepoetin Alfa Once Biweekly

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CERA Treatment Once Monthly n=46 participants at risk CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 participants at risk Darbepoetin Alfa as prescribed
Blood and lymphatic system disorders Lymphadenopathy	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Cardiac disorders Arrhythmia	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	4.0% 1/25 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Gastroenteritis	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Pyelonephritis	4.3% 2/46 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	4.0% 1/25 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Respiratory Tract Infection	4.3% 2/46 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Urinary Tract Infection	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Injury, poisoning and procedural complications Device Breakage	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Nervous system disorders Sciatica	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Renal and urinary disorders Proteinuria	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Laryngeal Granuloma	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Vascular disorders Aneurysm	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.

Other adverse events

Other adverse events
Measure	CERA Treatment Once Monthly n=46 participants at risk CERA 120, 200 or 360 micrograms subcutaneously	Darbepoetin Alfa Once Biweekly n=25 participants at risk Darbepoetin Alfa as prescribed
Gastrointestinal disorders Diarrhoea	8.7% 4/46 • Number of events 4 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
General disorders Asthenia	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
General disorders Fatigue	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	12.0% 3/25 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
General disorders Oedema	4.3% 2/46 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
General disorders Oedema Peripheral	6.5% 3/46 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	12.0% 3/25 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Escherichia Urinary Tract Infection	10.9% 5/46 • Number of events 5 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Influenza	6.5% 3/46 • Number of events 4 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	4.0% 1/25 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Nasopharyngitis	4.3% 2/46 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	16.0% 4/25 • Number of events 4 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Upper Respiratory Tract Infection	13.0% 6/46 • Number of events 6 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	0.00% 0/25 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Infections and infestations Urinary Tract Infection	8.7% 4/46 • Number of events 4 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 1/46 • Number of events 1 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	8.0% 2/25 • Number of events 2 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Vascular disorders Hypertension	19.6% 9/46 • Number of events 9 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.	12.0% 3/25 • Number of events 3 • Up to 28 weeks The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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