Trial Outcomes & Findings for A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia (NCT NCT02434497)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

96 weeks

Results posted on

2018-02-27

Participant Flow

The nine (9) patients recruited were all participants in the D3561C00004 HYDRA study (NCT02226198) four came from Sequence A and five from Sequence B

Participant milestones

Participant milestones
Measure	Overall All patients
Overall Study STARTED	9
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=9 Participants All patients
Age, Continuous	10.6 years STANDARD_DEVIATION 2.83 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
The Number of Participants Who Experianced Adverse Events and Serious Adverse Events	5 participants	—

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events	0 participants	—

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 60	1 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Growth, Height Week 96	165.0 cm Standard Deviation 25.46	138.0 cm Standard Deviation 12.73
Safety and Tolerability in Terms of Growth, Height Baseline	142.5 cm Standard Deviation 23.57	136.8 cm Standard Deviation 15.02
Safety and Tolerability in Terms of Growth, Height Week 6	143.5 cm Standard Deviation 23.57	136.8 cm Standard Deviation 15.32
Safety and Tolerability in Terms of Growth, Height Week 12	144.0 cm Standard Deviation 23.90	137.6 cm Standard Deviation 14.94
Safety and Tolerability in Terms of Growth, Height Week 18	145.3 cm Standard Deviation 23.56	138.0 cm Standard Deviation 14.83
Safety and Tolerability in Terms of Growth, Height Week 24	145.8 cm Standard Deviation 24.02	139.2 cm Standard Deviation 15.74
Safety and Tolerability in Terms of Growth, Height Week 36	147.0 cm Standard Deviation 24.15	140.6 cm Standard Deviation 15.61
Safety and Tolerability in Terms of Growth, Height Week 48	148.8 cm Standard Deviation 24.25	142.2 cm Standard Deviation 15.21
Safety and Tolerability in Terms of Growth, Height Week 60	158.0 cm Standard Deviation 19.47	144.0 cm Standard Deviation 16.37
Safety and Tolerability in Terms of Growth, Height Week 72	159.0 cm Standard Deviation 20.22	145.0 cm Standard Deviation 15.12
Safety and Tolerability in Terms of Growth, Height Week 84	159.7 cm Standard Deviation 20.43	148.3 cm Standard Deviation 17.27

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation	0 participants	—

PRIMARY outcome

Timeframe: 96 weeks

Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean.

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Baseline	-0.43 standard deviations Standard Deviation 2.025	-1.05 standard deviations Standard Deviation 1.787
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 6	-0.48 standard deviations Standard Deviation 1.911	-1.05 standard deviations Standard Deviation 1.871
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 12	-0.41 standard deviations Standard Deviation 1.975	-1.19 standard deviations Standard Deviation 1.709
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 18	-0.43 standard deviations Standard Deviation 1.610	-1.14 standard deviations Standard Deviation 1.705
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 24	-0.60 standard deviations Standard Deviation 1.730	-0.96 standard deviations Standard Deviation 1.670
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 36	-0.43 standard deviations Standard Deviation 1.836	-0.76 standard deviations Standard Deviation 1.727
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 48	-0.16 standard deviations Standard Deviation 1.781	-0.72 standard deviations Standard Deviation 1.729
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 60	0.05 standard deviations Standard Deviation 1.757	-1.04 standard deviations Standard Deviation 1.604
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 72	0.00 standard deviations Standard Deviation 1.635	-0.87 standard deviations Standard Deviation 1.604
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 84	0.08 standard deviations Standard Deviation 1.734	-0.33 standard deviations Standard Deviation 1.627
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) Week 96	1.18 standard deviations Standard Deviation 0.436	-0.51 standard deviations Standard Deviation 0.886

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Growth, Weight Week 84	50.17 kg Standard Deviation 16.737	45.28 kg Standard Deviation 19.143
Safety and Tolerability in Terms of Growth, Weight Week 96	57.35 kg Standard Deviation 16.476	33.55 kg Standard Deviation 2.192
Safety and Tolerability in Terms of Growth, Weight Baseline	36.25 kg Standard Deviation 14.719	37.42 kg Standard Deviation 16.089
Safety and Tolerability in Terms of Growth, Weight Week 6	37.20 kg Standard Deviation 16.230	38.02 kg Standard Deviation 16.700
Safety and Tolerability in Terms of Growth, Weight Week 12	37.93 kg Standard Deviation 17.110	38.16 kg Standard Deviation 17.501
Safety and Tolerability in Terms of Growth, Weight Week 18	38.85 kg Standard Deviation 17.633	38.40 kg Standard Deviation 16.688
Safety and Tolerability in Terms of Growth, Weight Week 24	39.15 kg Standard Deviation 17.521	39.00 kg Standard Deviation 16.704
Safety and Tolerability in Terms of Growth, Weight Week 36	39.98 kg Standard Deviation 18.293	39.88 kg Standard Deviation 15.015
Safety and Tolerability in Terms of Growth, Weight Week 48	41.00 kg Standard Deviation 17.579	41.16 kg Standard Deviation 16.045
Safety and Tolerability in Terms of Growth, Weight Week 60	48.47 kg Standard Deviation 16.933	41.80 kg Standard Deviation 15.656
Safety and Tolerability in Terms of Growth, Weight Week 72	48.43 kg Standard Deviation 16.393	42.10 kg Standard Deviation 17.047

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 96	0 participants 25.46	0 participants 12.73
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN Week 60	0 participants 19.47	1 participants 16.37

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Baseline	0 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 6	0 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 12	1 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 24	1 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 36	1 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 48	1 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 60	1 participants 19.47	3 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 72	2 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 84	1 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN Week 96	0 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Baseline	2 participants 23.57	3 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 6	0 participants 23.57	2 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 12	2 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 18	1 participants 23.56	2 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 24	2 participants 24.02	3 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 36	1 participants 24.15	3 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 48	1 participants 24.25	4 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 60	1 participants 19.47	4 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 72	2 participants 20.22	3 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 84	2 participants 20.43	3 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN Week 96	0 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Baseline	1 participants 23.57	3 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 6	1 participants 23.57	2 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 12	1 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 18	1 participants 23.56	2 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 24	1 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 36	1 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 48	1 participants 24.25	3 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 60	0 participants 19.47	3 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 72	0 participants 20.22	3 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 84	0 participants 20.43	3 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN Week 96	2 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Baseline	1 participants 23.57	2 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 6	1 participants 23.57	2 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 12	1 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 18	1 participants 23.56	2 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 24	1 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 36	1 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 48	1 participants 24.25	2 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 60	0 participants 19.47	2 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 72	0 participants 20.22	3 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 84	0 participants 20.43	3 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN Week 96	2 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 84	1 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Baseline	1 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Baseline	0 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 24	1 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 36	0 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 72	0 participants 20.22	2 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 84	0 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN Week 96	0 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Baseline	2 participants 23.57	2 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 6	2 participants 23.57	3 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 12	1 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 18	1 participants 23.56	3 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 36	1 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 48	0 participants 24.25	2 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 60	0 participants 19.47	2 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 84	0 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Baseline	2 participants 23.57	3 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 6	2 participants 23.57	3 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 12	1 participants 23.90	3 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 18	1 participants 23.56	3 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 24	0 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 36	1 participants 24.15	3 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 48	1 participants 24.25	3 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 60	0 participants 19.47	3 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 72	0 participants 20.22	3 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 84	0 participants 20.43	3 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN Week 96	0 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Baseline	0 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 6	0 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Baseline	1 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 6	0 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Baseline	1 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 6	1 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 12	1 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 18	1 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 48	1 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Baseline	0 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 6	0 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 36	1 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 6	1 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 24	1 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 60	1 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN Week 96	1 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 84	0 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 96	0 participants 25.46	0 participants 12.73
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN Week 84	0 participants 20.43	1 participants 17.27

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 36	1 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Baseline	2 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 6	1 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 18	3 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Baseline	1 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 6	1 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 12	1 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 18	1 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 24	1 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 36	1 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 48	1 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 60	1 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 72	1 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 84	1 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN Week 96	1 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones Week 96	1 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 60	1 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 72	2 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 84	1 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 96	0 participants 25.46	0 participants 12.73
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Baseline	1 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 6	2 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 12	1 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 18	1 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 24	1 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 36	1 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood Week 48	1 participants 24.25	1 participants 15.21

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 72	3 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 84	2 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 96	1 participants 25.46	0 participants 12.73
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Baseline	2 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 12	2 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 6	1 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 18	1 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 24	2 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 36	2 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 48	1 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein Week 60	3 participants 19.47	1 participants 16.37

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal ECG, Abnormalities Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal ECG, Abnormalities Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal ECG, Abnormalities Final Visit	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 12	1 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 18	1 participants 23.56	2 participants 14.83
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 24	1 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 36	1 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Baseline	1 participants 23.57	2 participants 15.02
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 6	1 participants 23.57	2 participants 15.32
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 48	1 participants 24.25	2 participants 15.21
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 60	1 participants 19.47	2 participants 16.37
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 72	1 participants 20.22	2 participants 15.12
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 84	1 participants 20.43	2 participants 17.27
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 36	0 participants 24.15	1 participants 15.61
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Baseline	0 participants 23.57	1 participants 15.02
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 6	0 participants 23.57	1 participants 15.32
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 12	0 participants 23.90	1 participants 14.94
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 18	0 participants 23.56	1 participants 14.83
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 24	0 participants 24.02	1 participants 15.74
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 60	0 participants 19.47	1 participants 16.37
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 72	0 participants 20.22	1 participants 15.12
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 48	0 participants 24.25	1 participants 15.21
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities Week 96	0 participants 25.46	0 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Baseline	3 participants 23.57	2 participants 15.02
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 6	3 participants 23.57	2 participants 15.32
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 12	3 participants 23.90	2 participants 14.94
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 18	3 participants 23.56	2 participants 14.83
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 24	3 participants 24.02	2 participants 15.74
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 36	3 participants 24.15	2 participants 15.61
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 48	3 participants 24.25	2 participants 15.21
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 60	2 participants 19.47	2 participants 16.37
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 72	2 participants 20.22	2 participants 15.12
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 84	2 participants 20.43	1 participants 17.27
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin Week 96	2 participants 25.46	1 participants 12.73

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Full Analysis Set n=4 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B n=5 Participants Placebo/Rosuva in the D3561C00004 cross-over phase
Safety and Tolerability in Terms of Abnormal Vital Signs Baseline	0 participants 23.57	0 participants 15.02
Safety and Tolerability in Terms of Abnormal Vital Signs Week 6	0 participants 23.57	0 participants 15.32
Safety and Tolerability in Terms of Abnormal Vital Signs Week 12	0 participants 23.90	0 participants 14.94
Safety and Tolerability in Terms of Abnormal Vital Signs Week 18	0 participants 23.56	0 participants 14.83
Safety and Tolerability in Terms of Abnormal Vital Signs Week 24	0 participants 24.02	0 participants 15.74
Safety and Tolerability in Terms of Abnormal Vital Signs Week 36	0 participants 24.15	0 participants 15.61
Safety and Tolerability in Terms of Abnormal Vital Signs Week 48	0 participants 24.25	0 participants 15.21
Safety and Tolerability in Terms of Abnormal Vital Signs Week 60	0 participants 19.47	0 participants 16.37
Safety and Tolerability in Terms of Abnormal Vital Signs Week 72	0 participants 20.22	0 participants 15.12
Safety and Tolerability in Terms of Abnormal Vital Signs Week 84	0 participants 20.43	0 participants 17.27
Safety and Tolerability in Terms of Abnormal Vital Signs Week 96	0 participants 25.46	0 participants 12.73

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-21.0 % change from baseline LDL-C Interval -32.1 to -8.0	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-18.6 % change from baseline LDL-C Interval -28.4 to -7.4	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-14.7 % change from baseline LDL-C Interval -25.2 to -2.8	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-12.1 % change from baseline LDL-C Interval -23.8 to 1.4	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-21.3 % change from baseline LDL-C Interval -33.7 to -6.6	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-20.5 % change from baseline LDL-C Interval -33.6 to -4.8	—
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-12.4 % change from baseline LDL-C Interval -28.2 to 7.0	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	12.3 % change from baseline HDL-C Interval 1.3 to 24.5	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	19.0 % change from baseline HDL-C Interval 6.2 to 33.4	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	5.2 % change from baseline HDL-C Interval -8.4 to 20.8	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	4.4 % change from baseline HDL-C Interval -10.8 to 22.2	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	4.4 % change from baseline HDL-C Interval -12.7 to 24.9	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	9.4 % change from baseline HDL-C Interval -9.4 to 32.1	—
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	3.8 % change from baseline HDL-C Interval -13.1 to 23.9	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-19.4 % change from baseline TC Interval -29.7 to -7.6	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-16.8 % change from baseline TC Interval -25.7 to -6.8	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-14.0 % change from baseline TC Interval -23.6 to -3.3	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-11.8 % change from baseline TC Interval -22.3 to 0.1	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-19.9 % change from baseline TC Interval -31.1 to -6.9	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-18.3 % change from baseline TC Interval -30.2 to -4.3	—
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-11.9 % change from baseline TC Interval -26.3 to 5.2	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-17.4 % change from baseline TG Interval -34.2 to 3.8	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-16.2 % change from baseline TG Interval -36.1 to 10.1	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-22.0 % change from baseline TG Interval -42.8 to 6.5	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-17.3 % change from baseline TG Interval -31.9 to 0.5	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-23.3 % change from baseline TG Interval -45.0 to 7.1	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-21.7 % change from baseline TG Interval -43.4 to 8.4	—
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-28.5 % change from baseline TG Interval -47.0 to -3.6	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-21.7 % change from baseline Non-HDL-C Interval -32.7 to -9.0	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-19.2 % change from baseline Non-HDL-C Interval -28.8 to -8.3	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-15.7 % change from baseline Non-HDL-C Interval -25.7 to -4.3	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-13.3 % change from baseline Non-HDL-C Interval -24.3 to -0.7	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-22.1 % change from baseline Non-HDL-C Interval -33.8 to -8.4	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-21.0 % change from baseline Non-HDL-C Interval -33.2 to -6.5	—
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-13.2 % change from baseline Non-HDL-C Interval -28.1 to 4.8	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-35.0 % change from baseline LDL-C/HDL-C Interval -49.5 to -16.4	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-48.6 % change from baseline LDL-C/HDL-C Interval -61.3 to -31.7	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-39.4 % change from baseline LDL-C/HDL-C Interval -51.6 to -24.1	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-41.2 % change from baseline LDL-C/HDL-C Interval -52.8 to -26.9	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-36.1 % change from baseline LDL-C/HDL-C Interval -48.8 to -20.2	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-42.2 % change from baseline LDL-C/HDL-C Interval -57.2 to -21.9	—
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-27.8 % change from baseline LDL-C/HDL-C Interval -47.4 to -0.9	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-16.6 % change from baseline TC/HDL-C Interval -30.7 to 0.4	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-24.1 % change from baseline TC/HDL-C Interval -38.6 to -6.2	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-30.6 % change from baseline TC/HDL-C Interval -38.3 to -21.9	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-29.4 % change from baseline TC/HDL-C Interval -38.5 to -18.9	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-20.5 % change from baseline TC/HDL-C Interval -32.0 to -7.0	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-29.2 % change from baseline TC/HDL-C Interval -43.2 to -11.7	—
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-15.6 % change from baseline TC/HDL-C Interval -33.7 to 7.5	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-32.9 % change from baseline Non-HDL-C/HDL-C Interval -41.2 to -23.3	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-31.5 % change from baseline Non-HDL-C/HDL-C Interval -41.2 to -20.3	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-22.3 % change from baseline Non-HDL-C/HDL-C Interval -34.3 to -8.1	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-18.1 % change from baseline Non-HDL-C/HDL-C Interval -32.8 to -0.3	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-26.3 % change from baseline Non-HDL-C/HDL-C Interval -41.3 to -7.4	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-31.8 % change from baseline Non-HDL-C/HDL-C Interval -46.0 to -13.9	—
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-17.6 % change from baseline Non-HDL-C/HDL-C Interval -36.2 to 6.5	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-20.5 % change from baseline ApoB Interval -29.8 to -9.9	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-18.7 % change from baseline ApoB Interval -26.7 to -9.8	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-15.2 % change from baseline ApoB Interval -23.9 to -5.6	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-10.5 % change from baseline ApoB Interval -20.4 to 0.5	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-17.2 % change from baseline ApoB Interval -27.9 to -4.9	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-19.2 % change from baseline ApoB Interval -30.2 to -6.5	—
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-9.5 % change from baseline ApoB Interval -23.5 to 7.2	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	8.0 % change from baseline ApoA-1 Interval 0.0 to 16.6	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	7.0 % change from baseline ApoA-1 Interval -2.3 to 17.1	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	5.3 % change from baseline ApoA-1 Interval -4.9 to 16.7	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	6.5 % change from baseline ApoA-1 Interval -5.3 to 19.7	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	1.0 % change from baseline ApoA-1 Interval -11.5 to 15.3	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	10.7 % change from baseline ApoA-1 Interval -2.6 to 25.7	—
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	1.6 % change from baseline ApoA-1 Interval -12.9 to 18.4	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=9 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 1	-23.3 % change from baseline ApoB/ApoA-1 Interval -34.3 to -10.5	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 2	-22.1 % change from baseline ApoB/ApoA-1 Interval -32.7 to -9.8	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 3	-18.9 % change from baseline ApoB/ApoA-1 Interval -31.2 to -4.4	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 4	-15.7 % change from baseline ApoB/ApoA-1 Interval -30.2 to 1.7	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 5	-17.0 % change from baseline ApoB/ApoA-1 Interval -33.1 to 2.8	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 6	-26.0 % change from baseline ApoB/ApoA-1 Interval -41.1 to -7.0	—
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis Visit 7	-14.7 % change from baseline ApoB/ApoA-1 Interval -33.7 to 9.7	—

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome measures
Measure	Full Analysis Set n=1 Participants Full analysis set, comprised of patient who received at least one dose of study drug.	Sequence B Placebo/Rosuva in the D3561C00004 cross-over phase
Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg Day 292	9.00 ng/mL	—
Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg Day 376	7.14 ng/mL	—

Adverse Events

Overall

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall n=9 participants at risk All patients
Infections and infestations Nasopharyngitis	22.2% 2/9 • Number of events 2 • 72 weeks
Infections and infestations Otitis externa	11.1% 1/9 • Number of events 1 • 72 weeks
Infections and infestations Upper respiratory tract infection	11.1% 1/9 • Number of events 1 • 72 weeks
Renal and urinary disorders Dysuria	11.1% 1/9 • Number of events 1 • 72 weeks
Renal and urinary disorders Proteinuria	11.1% 1/9 • Number of events 1 • 72 weeks
General disorders Chest discomfort	11.1% 1/9 • Number of events 1 • 72 weeks
Injury, poisoning and procedural complications Ligament sprain	11.1% 1/9 • Number of events 1 • 72 weeks
Psychiatric disorders Attention deficit/hyperactivity disorder	11.1% 1/9 • Number of events 1 • 72 weeks
Reproductive system and breast disorders Dysmenorrhoea	11.1% 1/9 • Number of events 1 • 72 weeks

Additional Information

Robin Mukherjee

AstraZeneca Plc

Phone: +46317761000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Upon completion of the Clinical Trial (CT), the Principal Investigator (PI) may prepare the data derived from the CT for publication or presentation. Material should be submitted to the Sponsor for review prior to review or submission for publication. Publications from individual sites must not precede the primary manuscript, but if published within twelve months after completion of the CT, the PI has the right to publish or present the methods and results of the CT.
Publication restrictions are in place

Restriction type: OTHER