Trial Outcomes & Findings for STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients (NCT NCT00642850)

Last Updated: 2016-06-23

Results Overview

Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis 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 up to Week 24) was estimated as a time adjusted average.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

188 participants

Primary outcome timeframe

Week 17 up to Week 24

Results posted on

2016-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	C.E.R.A. Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
Overall Study STARTED	188
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	C.E.R.A. Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
Overall Study Death	7
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	1
Overall Study Protocol Violation	2
Overall Study Kidney transplantation	8
Overall Study Blood transfusion	6
Overall Study Other reasons	7

Baseline Characteristics

STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C.E.R.A. n=188 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Age, Continuous	64.9 years STANDARD_DEVIATION 11.56 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 17 up to Week 24

Population: Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=154 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range	53.3 percentage of participants Interval 45.1 to 61.3

SECONDARY outcome

Timeframe: Week -4 up to Week -1 and Week 17 up to Week 24

Population: The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available.

The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Change in Hemoglobin Concentration Between Reference (SVP) and EEP	0.0 g/dL Standard Deviation 1.21

SECONDARY outcome

Timeframe: Week 17 up to Week 24

Population: ITT Population.

Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP	57.0 percentage of participants Interval 49.5 to 64.2

SECONDARY outcome

Timeframe: Week 17 up to Week 24

Population: ITT Population.

Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP	32 days Standard Deviation 18.4

SECONDARY outcome

Timeframe: Week 1 to Week 16 and Week 17 to Week 24

Population: ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category.

Percentage of participants requiring 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.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Percentage of Participants Requiring Any Dose Adjustment DTP (n = 186)	75.0 percentage of participants
Percentage of Participants Requiring Any Dose Adjustment EEP (n = 165)	32.0 percentage of participants

SECONDARY outcome

Timeframe: Week -4 up to Week 28

Population: ITT Population.

Number of participant who underwent red blood cell transfusion during the study was reported.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Number of Participants With Red Blood Cell Transfusion During the Study	9 participants

SECONDARY outcome

Timeframe: Week -4 and at early withdrawal or Week 28

Population: ITT Population.

Outcome measures

Outcome measures
Measure	C.E.R.A. n=186 Participants Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Number of Participants With Anti-epoetin Antibody Week -4	0 participants
Number of Participants With Anti-epoetin Antibody Early Withdrawal or Week 28	0 participants

Adverse Events

C.E.R.A.

Serious events: 41 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	C.E.R.A. n=188 participants at risk Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Cardiac disorders Angina pectoris	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Atrial fibrillation	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Atrioventricular block	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Cardiac arrest	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Cardiac failure	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Myocardial ischaemia	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Cardiac disorders Ventricular fibrillation	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Coeliac artery stenosis	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Dyspepsia	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Gastric ulcer perforation	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Intestinal angina	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Gastrointestinal disorders Intestinal haemorrhage	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
General disorders Sudden death	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Arteriovenous fistula site infection	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Bronchitis	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Catheter sepsis	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Chlamydial infection	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Gastroenteritis	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Haematoma infection	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Herpes zoster	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Sepsis	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Wound infection staphylococcal	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Accident	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Complications of transplanted kidney	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Concussion	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Femur fracture	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Graft complication	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Humerus fracture	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Investigations Arteriogram	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Investigations Arteriogram coronary	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Metabolism and nutrition disorders Fluid retention	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Nervous system disorders Carotid artery stenosis	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Nervous system disorders Cerebral haemorrhage	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Nervous system disorders Cerebrovascular accident	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Nervous system disorders Subarachnoid haemorrhage	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Nervous system disorders Transient ischaemic attack	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Reproductive system and breast disorders Breast dysplasia	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Respiratory, thoracic and mediastinal disorders Hydrothorax	1.1% 2/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Skin and subcutaneous tissue disorders Dry gangrene	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Surgical and medical procedures Arteriovenous fistula operation	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Surgical and medical procedures Coronary artery bypass	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Surgical and medical procedures Surgery	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Vascular disorders Aneurysm ruptured	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Vascular disorders Hypertension	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Vascular disorders Shock	0.53% 1/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.

Other adverse events

Other adverse events
Measure	C.E.R.A. n=188 participants at risk Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
Gastrointestinal disorders Diarrhoea	5.9% 11/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Infections and infestations Bronchitis	5.3% 10/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.
Vascular disorders Hypertension	11.7% 22/188 • Up to 28 weeks Only adverse events with an onset date after the start of medication included.

Additional Information

Medical Communications

Hoffmann-LaRoche

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