Trial Outcomes & Findings for A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis (NCT NCT00737477)

Last Updated: 2017-06-23

Results Overview

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

96 participants

Primary outcome timeframe

Weeks 16 to 24

Results posted on

2017-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Mircera in Chronic Kidney Disease (CKD)-Related Anemia Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Overall Study STARTED	96
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Mircera in Chronic Kidney Disease (CKD)-Related Anemia Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Overall Study Adverse Event	9
Overall Study Death	9
Overall Study Treatment Refusal	1
Overall Study Withdrawal by Subject	1
Overall Study Renal Transplantation	10
Overall Study Other	4

Baseline Characteristics

A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Age, Continuous	67.9 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 16 to 24

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=80 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP	50.0 percentage of participants Interval 39.0 to 61.0

SECONDARY outcome

Timeframe: Weeks 16 to 24

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table.

During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=80 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants With Hb Values Within Target Range During the EEP At Least One Hb Value (n=80)	78.8 percentage of participants
Percentage of Participants With Hb Values Within Target Range During the EEP At Least Two Hb Values (n=77)	49.4 percentage of participants
Percentage of Participants With Hb Values Within Target Range During the EEP All Three Hb Values (n=74)	23.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 16 to 24

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data.

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=80 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Change in Hb Value From Baseline to the EEP	0.4 g/dL Standard Deviation 0.9

SECONDARY outcome

Timeframe: Weeks 16 to 24 and Weeks 0 to 48

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table.

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=94 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period EEP (Weeks 16 to 24; n=80)	5.9 weeks Standard Deviation 4.2
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period Overall Study (Weeks 0 to 48; n=94)	22.0 weeks Standard Deviation 13.8

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 16 (n=80)	37.5 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 20 (n=76)	35.5 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 24 (n=75)	44.0 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 28 (n=73)	39.7 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 32 (n=72)	44.4 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 36 (n=68)	51.5 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 40 (n=65)	44.6 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 44 (n=63)	44.4 percentage of participants
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Week 48 (n=62)	38.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 to 44

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data.

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (\>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) \>1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants With Cycles or Excursions At Least One Cycle	5.3 percentage of participants
Percentage of Participants With Cycles or Excursions At Least One Excursion	60.0 percentage of participants
Percentage of Participants With Cycles or Excursions At Least One Up Excursion	46.3 percentage of participants
Percentage of Participants With Cycles or Excursions At Least One Down Excursion	18.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants with at least one up excursion.

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=44 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants With Up Excursions Weeks 16 to 24	45.5 percentage of participants
Percentage of Participants With Up Excursions Weeks 4 to 16	31.8 percentage of participants
Percentage of Participants With Up Excursions Weeks 24 to 44	22.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants with at least one down excursion.

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=18 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants With Down Excursions Weeks 4 to 16	16.7 percentage of participants
Percentage of Participants With Down Excursions Weeks 16 to 24	11.1 percentage of participants
Percentage of Participants With Down Excursions Weeks 24 to 44	72.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Any Dose Adjustment, Weeks 4 to 20 (n=95)	84.2 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Decreased Dose, Weeks 4 to 20 (n=75)	69.3 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Increased Dose, Weeks 4 to 20 (n=75)	43.3 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Dose Not Performed, Weeks 4 to 20 (n=95)	34.7 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Any Dose Adjustment, Weeks 24 to 48 (n=76)	100 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Decreased Dose, Weeks 24 to 48 (n=50)	74.0 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Increased Dose, Weeks 24 to 48 (n=50)	46.0 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Dose Not Performed, Weeks 24 to 48 (n=76)	30.3 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Any Dose Adjustment, Weeks 4 to 48 (n=95)	96.8 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Decreased Dose, Weeks 4 to 48 (n=94)	84.0 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Increased Dose, Weeks 4 to 48 (n=94)	71.3 percentage of participants
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Dose Not Performed, Weeks 4 to 48 (n=95)	47.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Number of Dose Adjustments of Mircera/CERA Weeks 4 to 20 (n=95)	2.0 dose adjustments Standard Deviation 1.3
Number of Dose Adjustments of Mircera/CERA Weeks 24 to 48 (n=76)	5.6 dose adjustments Standard Deviation 1.3
Number of Dose Adjustments of Mircera/CERA Weeks 4 to 48 (n=95)	3.3 dose adjustments Standard Deviation 2.0

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Absolute Change in Dose of Mircera/CERA by Study Week Week 4, Dose Decrease (n=25)	25.8 mcg Standard Deviation 11.9
Absolute Change in Dose of Mircera/CERA by Study Week Week 4, Dose Increase (n=9)	37.8 mcg Standard Deviation 17.2
Absolute Change in Dose of Mircera/CERA by Study Week Week 8, Dose Decrease (n=32)	28.4 mcg Standard Deviation 12.3
Absolute Change in Dose of Mircera/CERA by Study Week Week 8, Dose Increase (n=14)	42.9 mcg Standard Deviation 24.6
Absolute Change in Dose of Mircera/CERA by Study Week Week 12, Dose Decrease (n=21)	24.5 mcg Standard Deviation 3.5
Absolute Change in Dose of Mircera/CERA by Study Week Week 12, Dose Increase (n=8)	52.5 mcg Standard Deviation 21.7
Absolute Change in Dose of Mircera/CERA by Study Week Week 16, Dose Decrease (n=20)	24.0 mcg Standard Deviation 2.6
Absolute Change in Dose of Mircera/CERA by Study Week Week 16, Dose Increase (n=8)	47.5 mcg Standard Deviation 29.0
Absolute Change in Dose of Mircera/CERA by Study Week Week 20, Dose Decrease (n=11)	29.1 mcg Standard Deviation 15.3
Absolute Change in Dose of Mircera/CERA by Study Week Week 20, Dose Increase (n=10)	34.5 mcg Standard Deviation 11.2
Absolute Change in Dose of Mircera/CERA by Study Week Week 24, Dose Decrease (n=18)	29.0 mcg Standard Deviation 12.2
Absolute Change in Dose of Mircera/CERA by Study Week Week 24, Dose Increase (n=10)	50.5 mcg Standard Deviation 26.0
Absolute Change in Dose of Mircera/CERA by Study Week Week 28, Dose Decrease (n=13)	38.5 mcg Standard Deviation 22.0
Absolute Change in Dose of Mircera/CERA by Study Week Week 28, Dose Increase (n=7)	35.0 mcg Standard Deviation 20.2
Absolute Change in Dose of Mircera/CERA by Study Week Week 32, Dose Decrease (n=10)	27.0 mcg Standard Deviation 8.8
Absolute Change in Dose of Mircera/CERA by Study Week Week 32, Dose Increase (n=8)	37.5 mcg Standard Deviation 19.1
Absolute Change in Dose of Mircera/CERA by Study Week Week 36, Dose Decrease (n=10)	28.5 mcg Standard Deviation 11.6
Absolute Change in Dose of Mircera/CERA by Study Week Week 36, Dose Increase (n=2)	75.0 mcg Standard Deviation 35.4
Absolute Change in Dose of Mircera/CERA by Study Week Week 40, Dose Decrease (n=11)	37.3 mcg Standard Deviation 26.8
Absolute Change in Dose of Mircera/CERA by Study Week Week 40, Dose Increase (n=4)	22.5 mcg Standard Deviation 2.9
Absolute Change in Dose of Mircera/CERA by Study Week Week 44, Dose Decrease (n=2)	18.5 mcg Standard Deviation 2.1
Absolute Change in Dose of Mircera/CERA by Study Week Week 44, Dose Increase (n=5)	32.0 mcg Standard Deviation 10.9
Absolute Change in Dose of Mircera/CERA by Study Week Week 48, Dose Decrease (n=0)	NA mcg Standard Deviation NA No dose decreases were performed at the designated visit.
Absolute Change in Dose of Mircera/CERA by Study Week Week 48, Dose Increase (n=2)	40.0 mcg Standard Deviation 14.1

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as \[(current dose minus previous week dose) divided by previous week dose\] multiplied by 100, and averaged among all participants.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percent Change in Dose of Mircera/CERA by Study Week Week 4, Dose Decrease (n=25)	23.7 percent change in dose Standard Deviation 9.0
Percent Change in Dose of Mircera/CERA by Study Week Week 4, Dose Increase (n=9)	22.2 percent change in dose Standard Deviation 6.7
Percent Change in Dose of Mircera/CERA by Study Week Week 8, Dose Decrease (n=32)	33.3 percent change in dose Standard Deviation 22.2
Percent Change in Dose of Mircera/CERA by Study Week Week 8, Dose Increase (n=14)	21.4 percent change in dose Standard Deviation 4.9
Percent Change in Dose of Mircera/CERA by Study Week Week 12, Dose Decrease (n=21)	30.3 percent change in dose Standard Deviation 10.0
Percent Change in Dose of Mircera/CERA by Study Week Week 12, Dose Increase (n=8)	22.0 percent change in dose Standard Deviation 2.3
Percent Change in Dose of Mircera/CERA by Study Week Week 16, Dose Decrease (n=20)	41.1 percent change in dose Standard Deviation 14.0
Percent Change in Dose of Mircera/CERA by Study Week Week 16, Dose Increase (n=8)	25.6 percent change in dose Standard Deviation 7.7
Percent Change in Dose of Mircera/CERA by Study Week Week 20, Dose Decrease (n=11)	57.6 percent change in dose Standard Deviation 60.7
Percent Change in Dose of Mircera/CERA by Study Week Week 20, Dose Increase (n=10)	21.5 percent change in dose Standard Deviation 4.6
Percent Change in Dose of Mircera/CERA by Study Week Week 24, Dose Decrease (n=18)	45.0 percent change in dose Standard Deviation 24.8
Percent Change in Dose of Mircera/CERA by Study Week Week 24, Dose Increase (n=10)	29.6 percent change in dose Standard Deviation 14.5
Percent Change in Dose of Mircera/CERA by Study Week Week 28, Dose Decrease (n=13)	38.5 percent change in dose Standard Deviation 12.0
Percent Change in Dose of Mircera/CERA by Study Week Week 28, Dose Increase (n=7)	29.7 percent change in dose Standard Deviation 7.1
Percent Change in Dose of Mircera/CERA by Study Week Week 32, Dose Decrease (n=10)	36.5 percent change in dose Standard Deviation 16.4
Percent Change in Dose of Mircera/CERA by Study Week Week 32, Dose Increase (n=8)	24.6 percent change in dose Standard Deviation 6.2
Percent Change in Dose of Mircera/CERA by Study Week Week 36, Dose Decrease (n=10)	43.7 percent change in dose Standard Deviation 15.5
Percent Change in Dose of Mircera/CERA by Study Week Week 36, Dose Increase (n=2)	22.5 percent change in dose Standard Deviation 3.5
Percent Change in Dose of Mircera/CERA by Study Week Week 40, Dose Decrease (n=11)	51.6 percent change in dose Standard Deviation 29.3
Percent Change in Dose of Mircera/CERA by Study Week Week 40, Dose Increase (n=4)	26.7 percent change in dose Standard Deviation 9.7
Percent Change in Dose of Mircera/CERA by Study Week Week 44, Dose Decrease (n=2)	35.8 percent change in dose Standard Deviation 22.3
Percent Change in Dose of Mircera/CERA by Study Week Week 44, Dose Increase (n=5)	24.0 percent change in dose Standard Deviation 8.9
Percent Change in Dose of Mircera/CERA by Study Week Week 48, Dose Decrease (n=0)	NA percent change in dose Standard Deviation NA No dose decreases were performed at the designated visit.
Percent Change in Dose of Mircera/CERA by Study Week Week 48, Dose Increase (n=2)	22.5 percent change in dose Standard Deviation 3.5

SECONDARY outcome

Timeframe: Weeks 0 to 48

Population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data.

The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.

Outcome measures

Outcome measures
Measure	Mircera in CKD-Related Anemia n=95 Participants Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Percentage of Participants Requiring Blood Transfusions	3.2 percentage of participants

Adverse Events

Mircera in CKD-Related Anemia

Serious events: 48 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mircera in CKD-Related Anemia n=96 participants at risk Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Gastrointestinal disorders Abdominal pain	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Abdominal strangulated hernia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Constipation	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Inguinal hernia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Intestinal polyp	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Oesophagitis haemorrhagic	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Oesophagitis ulcerative	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Peritoneal haemorrhage	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Peritonitis	7.3% 7/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Pneumoperitoneum	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Subileus	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Umbilical hernia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Vomiting	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Acute coronary syndrome	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Angina unstable	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Arrhythmia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Atrioventricular block	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Bradycardia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Cardiac arrest	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Cardiac failure	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Cardiac failure acute	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Cardiac disorders Myocardial ischaemia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Infections and infestations Laryngitis	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Infections and infestations Lung infection	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Infections and infestations Peritoneal candidiasis	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Infections and infestations Peritoneal infection	3.1% 3/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Infections and infestations Sepsis	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Asthenia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders General physical health deterioration	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Hyperthermia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Oedema	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Oedema peripheral	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Product contamination microbial	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Metabolism and nutrition disorders Fluid overload	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Metabolism and nutrition disorders Hypoglycaemia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Metabolism and nutrition disorders Hypokalaemia	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Nervous system disorders Coma	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Nervous system disorders Convulsion	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Nervous system disorders Mental impairment	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Nervous system disorders Sciatica	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Respiratory, thoracic and mediastinal disorders Asthma	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Vascular disorders Arterial disorder	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Vascular disorders Extremity necrosis	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Vascular disorders Peripheral arterial occlusive disease	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Vascular disorders Thrombosis	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Hepatobiliary disorders Cholecystitis acute	2.1% 2/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Musculoskeletal and connective tissue disorders Clavicle fracture	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Musculoskeletal and connective tissue disorders Femoral neck fracture	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Musculoskeletal and connective tissue disorders Spinal compression fracture	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Eye disorders Macular oedema	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Injury, poisoning and procedural complications Post procedural complication	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Investigations Blood glucose fluctuation	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Psychiatric disorders Confusional state	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Surgical and medical procedures Removal of ambulatory peritoneal catheter	1.0% 1/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.

Other adverse events

Other adverse events
Measure	Mircera in CKD-Related Anemia n=96 participants at risk Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
Gastrointestinal disorders Constipation	5.2% 5/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Gastrointestinal disorders Diarrhoea	5.2% 5/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Respiratory, thoracic and mediastinal disorders Bronchitis	11.5% 11/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Vascular disorders Hypertension	8.3% 8/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
General disorders Oedema peripheral	5.2% 5/96 • Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall) Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.

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