Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions
Brief summary
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
Interventions
DRUGCinacalcet
Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
DRUGVitamin D
Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study * Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 300 pg/mL (31.8 pmol/L); or biPTH \> 160 pg/mL (17.0 pmol/L) * Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L) * Subject will be able to complete the study, to the best of his/her knowledge * Before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion criteria
* Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 800 pg/mL (84.9 pmol/L); or biPTH \> 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening * Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening * Anticipated parathyroidectomy (partial or full) within 6 months after randomization * Have a scheduled date for kidney transplant surgery * Received cinacalcet since initiating hemodialysis * Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening * Subject is pregnant (eg, positive HCG test) or is breast-feeding * Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment) * Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets * Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance * Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator * Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Weeks 22-26 | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Weeks 48-52 | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Weeks 48-52 | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Weeks 22-26 | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Weeks 48-52 | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Weeks 22-26 | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Weeks 48-52 | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Weeks 22-26 and Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Weeks 22-26 and Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Weeks 22-26 and Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Weeks 22-26 and Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Weeks 22-26 | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase | Weeks 48-52 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
| Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 | Weeks 22-26 | Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL |
| Subject Incidence of Hypercalcemia During the Maintenance Phase | Weeks 26-48 | Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL |
| Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 | Weeks 48-52 | Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL |
| Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 | Weeks 22-26 | Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL |
| Subject Incidence of Hyperphosphatemia During the Maintenance Phase | Weeks 26-48 | Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL |
| Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 | Weeks 48-52 | Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL |
| Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase | Weeks 22-26 | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
Participant flow
Recruitment details
First participant was enrolled on 19 February 2009 and last participant completed the study on 5 July 2011. 313 participants were enrolled from 82 study centers in US, Europe, Canada, Australia and Russia.
Pre-assignment details
Once participants were determined to be eligible for the study, they entered a pre-randomization wash-out phase of 4 weeks (if receiving vitamin D at the time of enrollment). Four enrolled participants did not complete the pre-randomization wash-out phase and were not randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Cinacalcet cinacalcet in combination with low-dose active vitamin D (if prescribed) | 153 |
| Control Group Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines. | 151 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative decision | 2 | 3 |
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Death | 8 | 7 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Noncompliance | 3 | 0 |
| Overall Study | Other in electronic Case Report Form | 0 | 1 |
| Overall Study | Protocol criteria (other) | 0 | 2 |
| Overall Study | Protocol criteria (parathyroidectomy) | 1 | 1 |
| Overall Study | Protocol criteria (renal transplant) | 12 | 8 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Cinacalcet | Total | Control Group |
|---|---|---|---|
| Active Vitamin D Use Active Vitamin D use | 74 participants | 146 participants | 72 participants |
| Active Vitamin D Use No active Vitamin D use | 79 participants | 158 participants | 79 participants |
| Age, Continuous | 57.9 years STANDARD_DEVIATION 13.6 | 57.4 years STANDARD_DEVIATION 14.1 | 57.0 years STANDARD_DEVIATION 14.6 |
| Age, Customized >=65 years | 48 participants | 100 participants | 52 participants |
| Age, Customized Between 18 and 65 years | 105 participants | 204 participants | 99 participants |
| Albumin | 3.93 g/dL STANDARD_DEVIATION 0.39 | 3.91 g/dL STANDARD_DEVIATION 0.39 | 3.89 g/dL STANDARD_DEVIATION 0.4 |
| Corrected Serum Calcium | 9.30 mg/dL STANDARD_DEVIATION 0.69 | 9.22 mg/dL STANDARD_DEVIATION 0.6 | 9.14 mg/dL STANDARD_DEVIATION 0.49 |
| Dialysis Vintage | 7.29 months STANDARD_DEVIATION 2.54 | 7.16 months STANDARD_DEVIATION 2.66 | 7.02 months STANDARD_DEVIATION 2.78 |
| iPTH | 559.2 pg/mL STANDARD_DEVIATION 338.2 | 535.5 pg/mL STANDARD_DEVIATION 299.6 | 511.6 pg/mL STANDARD_DEVIATION 253.6 |
| Race/Ethnicity, Customized Aborigine | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 8 participants | 5 participants |
| Race/Ethnicity, Customized Black or African American | 28 participants | 59 participants | 31 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized White or Caucasian | 120 participants | 231 participants | 111 participants |
| Serum Phosphorus | 5.55 mg/dL STANDARD_DEVIATION 1.7 | 5.52 mg/dL STANDARD_DEVIATION 1.65 | 5.49 mg/dL STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 70 Participants | 126 Participants | 56 Participants |
| Sex: Female, Male Male | 83 Participants | 178 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 107 / 155 | 87 / 154 |
| serious Total, serious adverse events | 72 / 155 | 52 / 154 |
Outcome results
Primary
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders defined as >= 30% reduction in Mean PTH | 96 participants |
| Cinacalcet | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 57 participants |
| Control Group | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders defined as >= 30% reduction in Mean PTH | 58 participants |
| Control Group | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 93 participants |
Comparison: Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26 and Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a >= 30% reduction in mean iPTH | 74 participants |
| Cinacalcet | Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 79 participants |
| Control Group | Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a >= 30% reduction in mean iPTH | 42 participants |
| Control Group | Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 109 participants |
p-value: 0.0003Cochran-Mantel-Haenszel
Secondary
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders defined as >= 30% reduction in mean PTH | 97 participants |
| Cinacalcet | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 56 participants |
| Control Group | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders defined as >= 30% reduction in mean PTH | 72 participants |
| Control Group | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 79 participants |
p-value: 0.0139Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26 and Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean corrected calcium < 10.2 mg/dL | 145 participants |
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 8 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean corrected calcium < 10.2 mg/dL | 139 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 12 participants |
p-value: 0.3298Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders, a mean corrected calcium < 10.2 mg/dL | 146 participants |
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 7 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders, a mean corrected calcium < 10.2 mg/dL | 141 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 10 participants |
p-value: 0.4304Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders, a mean corrected calcium < 10.2 mg/dL | 151 participants |
| Cinacalcet | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 2 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders, a mean corrected calcium < 10.2 mg/dL | 144 participants |
| Control Group | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 7 participants |
p-value: 0.0875Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26 and Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean iPTH <= 300 pg/mL | 54 participants |
| Cinacalcet | Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 99 participants |
| Control Group | Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean iPTH <= 300 pg/mL | 39 participants |
| Control Group | Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 112 participants |
p-value: 0.0611Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders defined as a mean PTH <= 300 pg/mL | 80 participants |
| Cinacalcet | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 73 participants |
| Control Group | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders defined as a mean PTH <= 300 pg/mL | 67 participants |
| Control Group | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 84 participants |
p-value: 0.2386Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders defined as a mean PTH <= 300 pg/mL | 87 participants |
| Cinacalcet | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 66 participants |
| Control Group | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders defined as a mean PTH <= 300 pg/mL | 53 participants |
| Control Group | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 98 participants |
p-value: 0.0002Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26 and Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean serum phosphorus < 5.5 mg/dL | 71 participants |
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 82 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Responders, a mean serum phosphorus < 5.5 mg/dL | 64 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | Non responders | 87 participants |
p-value: 0.4436Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders, a mean serum phosphorus < 5.5 mg/dL | 81 participants |
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 72 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Responders, a mean serum phosphorus < 5.5 mg/dL | 80 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | Non responders | 71 participants |
p-value: 0.952Cochran-Mantel-Haenszel
Secondary
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 53 participants |
| Cinacalcet | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders, a mean phosphorus < 5.5 mg/dL | 100 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Responders, a mean phosphorus < 5.5 mg/dL | 85 participants |
| Control Group | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | Non responders | 66 participants |
p-value: 0.091Cochran-Mantel-Haenszel
Secondary
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 | 15 participants |
| Control Group | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 | 21 participants |
Secondary
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 | 11 participants |
| Control Group | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 | 22 participants |
Secondary
Subject Incidence of Hypercalcemia During the Maintenance Phase
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Time frame: Weeks 26-48
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hypercalcemia During the Maintenance Phase | 16 participants |
| Control Group | Subject Incidence of Hypercalcemia During the Maintenance Phase | 25 participants |
Secondary
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 | 74 participants |
| Control Group | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 | 83 participants |
Secondary
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 | 71 participants |
| Control Group | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 | 93 participants |
Secondary
Subject Incidence of Hyperphosphatemia During the Maintenance Phase
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Time frame: Weeks 26-48
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Subject Incidence of Hyperphosphatemia During the Maintenance Phase | 71 participants |
| Control Group | Subject Incidence of Hyperphosphatemia During the Maintenance Phase | 87 participants |
Secondary
Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase | 8.95 mg/dL |
| Control Group | Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase | 9.42 mg/dL |
p-value: <0.0001ANCOVA
Secondary
Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase | 8.66 mg/dL |
| Control Group | Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase | 9.30 mg/dL |
p-value: <0.0001ANCOVA
Secondary
Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | 293.95 pg/mL |
| Control Group | Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | 364.79 pg/mL |
p-value: 0.004ANCOVA
Secondary
Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | 291.15 pg/mL |
| Control Group | Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | 402.11 pg/mL |
p-value: <0.0001ANCOVA
Secondary
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase | -2.62 percent change |
| Control Group | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase | 2.37 percent change |
p-value: <0.0001ANCOVA
Secondary
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase | -5.68 percent change |
| Control Group | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase | 1.05 percent change |
p-value: <0.0001ANCOVA
Secondary
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | -34.15 percent change |
| Control Group | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | -12.41 percent change |
p-value: <0.0001ANCOVA
Secondary
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | -34.62 percent change |
| Control Group | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | -9.69 percent change |
p-value: <0.0001ANCOVA
Secondary
Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase | 3.21 percent change |
| Control Group | Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase | 4.26 percent change |
p-value: 0.7518ANCOVA
Secondary
Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase | -1.79 percent change |
| Control Group | Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase | 3.94 percent change |
p-value: 0.071ANCOVA
Secondary
Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 48-52
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase | 5.37 mg/dL |
| Control Group | Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase | 5.53 mg/dL |
p-value: 0.3546ANCOVA
Secondary
Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time frame: Weeks 22-26
Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cinacalcet | Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase | 5.11 mg/dL |
| Control Group | Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase | 5.52 mg/dL |
p-value: 0.0085ANCOVA