Hemodialysis, Secondary Hyperparathyroidism
Conditions
Keywords
Secondary hyperparathyroidism, Hemodialysis, paricalcitol
Brief summary
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
Detailed description
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
Interventions
DRUGParicalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Sponsors
Abbott Japan Co.,Ltd
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who completed 12 weeks of Study M10-309 (NCT00667576).
Exclusion criteria
* Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism. * Patients with progressive malignancy or clinically significant hepatic disease. * Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576). * Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With Hyperphosphatemia | Anytime during the study through Week 53 | The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study. |
| The Percentage of Participants With of Hypercalcemia | Anytime during the study through Week 53 | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study. |
Secondary
| Measure | Time frame |
|---|---|
| The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53) |
| Change in Mean iPTH | Every week from Baseline through Week 13 and every other week thereafter until Week 53 |
| Duration of 2 Consecutive iPTH Values <= 180 pg/mL | From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53) |
| The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| Duration of 2 Consecutive Decreases in iPTH >= 50% | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| The Mean Change in Intact Parathyroid Hormone (iPTH) | From Baseline to Final Visit (which could occur anytime between study initiation and Week 53) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With Hypercalcemia | Anytime from Week 13 through Week 53 | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53) |
Countries
Japan
Participant flow
Recruitment details
A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.
Pre-assignment details
One of the 107 subjects withdrew consent before receiving study drug in this study. 106 subjects were treated with study drug. Two of these subjects were not included in the Full Analysis Set for analysis of efficacy because of subject death (n = 1) and withdrawal of consent (n = 1).
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol 2 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 26 |
| Paricalcitol 2 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 29 |
| Paricalcitol 4 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 23 |
| Paricalcitol 4 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 26 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Admitted to hospital for 2 weeks | 0 | 0 | 1 | 0 |
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 |
| Overall Study | Difficult to travel to dialysis site | 0 | 0 | 1 | 0 |
| Overall Study | Missed 7 consecutive doses | 0 | 1 | 0 | 0 |
| Overall Study | Physician decision, change of therapy | 0 | 0 | 0 | 1 |
| Overall Study | Resumption criteria were not met | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 4 | 3 |
Baseline characteristics
| Characteristic | Paricalcitol 2 µg ± 2 µg | Paricalcitol 4 µg ± 1 µg | Paricalcitol 2 µg ± 1 µg | Paricalcitol 4 µg ± 2 µg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 9 Participants | 10 Participants | 10 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 14 Participants | 16 Participants | 16 Participants | 63 Participants |
| Age Continuous | 60.3 years STANDARD_DEVIATION 12.06 | 58.6 years STANDARD_DEVIATION 12.14 | 62.4 years STANDARD_DEVIATION 11.89 | 61.1 years STANDARD_DEVIATION 11.91 | 60.6 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Japan | 29 participants | 23 participants | 26 participants | 26 participants | 104 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 16 Participants | 9 Participants | 44 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 10 Participants | 17 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 27 | 30 / 30 | 23 / 23 | 26 / 26 |
| serious Total, serious adverse events | 8 / 27 | 6 / 30 | 6 / 23 | 4 / 26 |
Outcome results
Primary
The Percentage of Participants With Hyperphosphatemia
The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.
Time frame: Anytime during the study through Week 53
Population: All subjects who received at least 1 dose of paricalcitol in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With Hyperphosphatemia | 40.74 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With Hyperphosphatemia | 36.67 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With Hyperphosphatemia | 26.09 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With Hyperphosphatemia | 38.46 Percentage of participants |
Primary
The Percentage of Participants With of Hypercalcemia
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.
Time frame: Anytime during the study through Week 53
Population: All subjects who received at least 1 dose of paricalcitol in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With of Hypercalcemia | 40.74 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With of Hypercalcemia | 63.33 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With of Hypercalcemia | 60.87 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With of Hypercalcemia | 65.38 Percentage of participants |
Secondary
Change in Mean iPTH
Time frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Baseline | 517.7 pg/mL | Standard Deviation 208.9 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 6 | 292.4 pg/mL | Standard Deviation 246.21 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 25 | 207.1 pg/mL | Standard Deviation 159 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 1 | 543.5 pg/mL | Standard Deviation 227.63 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 10 | 232.3 pg/mL | Standard Deviation 192.04 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 47 | 250.2 pg/mL | Standard Deviation 162.72 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 27 | 233.8 pg/mL | Standard Deviation 154.92 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 51 | 278.0 pg/mL | Standard Deviation 180.69 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 9 | 245.1 pg/mL | Standard Deviation 226 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 41 | 224.0 pg/mL | Standard Deviation 119.93 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 5 | 356.6 pg/mL | Standard Deviation 250.28 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 29 | 233.4 pg/mL | Standard Deviation 169.07 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 49 | 271.0 pg/mL | Standard Deviation 183.26 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 13 | 268.6 pg/mL | Standard Deviation 205.67 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 19 | 235.3 pg/mL | Standard Deviation 153.17 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 31 | 241.3 pg/mL | Standard Deviation 148.54 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 43 | 249.8 pg/mL | Standard Deviation 145.48 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 45 | 247.7 pg/mL | Standard Deviation 148.75 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 4 | 363.7 pg/mL | Standard Deviation 226.01 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 33 | 238.8 pg/mL | Standard Deviation 151.08 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 7 | 255.0 pg/mL | Standard Deviation 213.14 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 11 | 253.6 pg/mL | Standard Deviation 160.57 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 21 | 226.4 pg/mL | Standard Deviation 133.54 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 35 | 242.4 pg/mL | Standard Deviation 154.48 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 53 | 258.6 pg/mL | Standard Deviation 173.45 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 12 | 237.7 pg/mL | Standard Deviation 161.57 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 3 | 463.4 pg/mL | Standard Deviation 219.02 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 37 | 277.7 pg/mL | Standard Deviation 155.17 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 8 | 241.5 pg/mL | Standard Deviation 213.32 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 15 | 264.2 pg/mL | Standard Deviation 165.97 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 23 | 238.5 pg/mL | Standard Deviation 190.65 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 39 | 275.5 pg/mL | Standard Deviation 156.2 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 17 | 260.3 pg/mL | Standard Deviation 150.59 |
| Paricalcitol 2 µg ± 1 µg | Change in Mean iPTH | Week 2 | 472.5 pg/mL | Standard Deviation 214.5 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 15 | 317.3 pg/mL | Standard Deviation 193.5 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 41 | 304.6 pg/mL | Standard Deviation 163.9 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 11 | 251.8 pg/mL | Standard Deviation 170.12 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 51 | 295.0 pg/mL | Standard Deviation 214.96 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 43 | 319.4 pg/mL | Standard Deviation 188.02 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 1 | 548.2 pg/mL | Standard Deviation 186.89 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 45 | 279.4 pg/mL | Standard Deviation 171.65 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 17 | 345.2 pg/mL | Standard Deviation 242.46 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Baseline | 502.5 pg/mL | Standard Deviation 158.02 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 53 | 254.8 pg/mL | Standard Deviation 143.86 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 10 | 219.7 pg/mL | Standard Deviation 155.85 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 47 | 272.0 pg/mL | Standard Deviation 160.91 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 7 | 200.4 pg/mL | Standard Deviation 157.93 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 49 | 277.7 pg/mL | Standard Deviation 212.64 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 19 | 314.9 pg/mL | Standard Deviation 209.3 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 9 | 193.0 pg/mL | Standard Deviation 139.02 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 21 | 301.0 pg/mL | Standard Deviation 188.52 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 6 | 244.7 pg/mL | Standard Deviation 183.57 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 23 | 309.3 pg/mL | Standard Deviation 212.15 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 12 | 267.1 pg/mL | Standard Deviation 200.43 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 25 | 298.7 pg/mL | Standard Deviation 207.91 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 5 | 312.4 pg/mL | Standard Deviation 204.53 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 27 | 293.6 pg/mL | Standard Deviation 193.28 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 29 | 267.7 pg/mL | Standard Deviation 173.87 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 4 | 378.9 pg/mL | Standard Deviation 228 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 31 | 287.9 pg/mL | Standard Deviation 151.7 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 13 | 282.6 pg/mL | Standard Deviation 192.29 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 33 | 293.9 pg/mL | Standard Deviation 175.41 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 3 | 451.8 pg/mL | Standard Deviation 198.15 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 35 | 290.7 pg/mL | Standard Deviation 150.82 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 8 | 185.3 pg/mL | Standard Deviation 145.92 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 37 | 294.7 pg/mL | Standard Deviation 176.56 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 2 | 478.8 pg/mL | Standard Deviation 189.24 |
| Paricalcitol 2 µg ± 2 µg | Change in Mean iPTH | Week 39 | 316.0 pg/mL | Standard Deviation 218.05 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 1 | 527.7 pg/mL | Standard Deviation 126.04 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 10 | 231.6 pg/mL | Standard Deviation 136.57 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 11 | 246.2 pg/mL | Standard Deviation 146.08 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 12 | 277.3 pg/mL | Standard Deviation 192.73 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 13 | 312.4 pg/mL | Standard Deviation 205.3 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 15 | 359.4 pg/mL | Standard Deviation 198.28 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 17 | 338.2 pg/mL | Standard Deviation 172.23 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 19 | 332.9 pg/mL | Standard Deviation 169.8 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 21 | 314.0 pg/mL | Standard Deviation 100.02 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 23 | 315.4 pg/mL | Standard Deviation 106.45 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 25 | 307.9 pg/mL | Standard Deviation 137.16 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 27 | 271.7 pg/mL | Standard Deviation 117.34 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 29 | 270.9 pg/mL | Standard Deviation 161.03 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 31 | 257.1 pg/mL | Standard Deviation 132.29 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 33 | 263.2 pg/mL | Standard Deviation 122 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 35 | 227.3 pg/mL | Standard Deviation 109.73 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 37 | 267.6 pg/mL | Standard Deviation 144.44 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 39 | 236.9 pg/mL | Standard Deviation 124.05 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 41 | 239.1 pg/mL | Standard Deviation 108.72 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 43 | 277.9 pg/mL | Standard Deviation 117.03 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 45 | 251.5 pg/mL | Standard Deviation 88.42 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 51 | 267.5 pg/mL | Standard Deviation 165.72 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 53 | 252.7 pg/mL | Standard Deviation 163.02 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 47 | 204.2 pg/mL | Standard Deviation 70.13 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 49 | 221.3 pg/mL | Standard Deviation 102.75 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Baseline | 510.9 pg/mL | Standard Deviation 110.73 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 2 | 408.0 pg/mL | Standard Deviation 120.17 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 3 | 337.0 pg/mL | Standard Deviation 130.9 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 4 | 286.8 pg/mL | Standard Deviation 123.4 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 5 | 251.6 pg/mL | Standard Deviation 97.55 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 6 | 222.6 pg/mL | Standard Deviation 109.8 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 7 | 198.1 pg/mL | Standard Deviation 110.03 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 8 | 200.0 pg/mL | Standard Deviation 89.35 |
| Paricalcitol 4 µg ± 1 µg | Change in Mean iPTH | Week 9 | 203.7 pg/mL | Standard Deviation 99.57 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 1 | 623.2 pg/mL | Standard Deviation 250.76 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 39 | 296.7 pg/mL | Standard Deviation 298.52 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 37 | 299.8 pg/mL | Standard Deviation 241.77 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 13 | 329.1 pg/mL | Standard Deviation 236.15 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 2 | 490.3 pg/mL | Standard Deviation 254.65 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 35 | 336.0 pg/mL | Standard Deviation 231.41 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 33 | 319.7 pg/mL | Standard Deviation 285.1 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 9 | 291.5 pg/mL | Standard Deviation 225.08 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 3 | 381.3 pg/mL | Standard Deviation 233.11 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 31 | 285.7 pg/mL | Standard Deviation 209.17 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 29 | 306.4 pg/mL | Standard Deviation 217.7 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 8 | 242.5 pg/mL | Standard Deviation 152.77 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 4 | 291.7 pg/mL | Standard Deviation 237.2 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 27 | 349.3 pg/mL | Standard Deviation 277.43 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 25 | 349.4 pg/mL | Standard Deviation 246.98 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 12 | 266.2 pg/mL | Standard Deviation 193.01 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 5 | 236.0 pg/mL | Standard Deviation 192.9 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 23 | 323.7 pg/mL | Standard Deviation 207.68 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 21 | 307.8 pg/mL | Standard Deviation 233.98 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 11 | 240.8 pg/mL | Standard Deviation 216.55 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 6 | 228.8 pg/mL | Standard Deviation 194.85 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 19 | 357.0 pg/mL | Standard Deviation 297.39 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 17 | 368.9 pg/mL | Standard Deviation 290.14 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 10 | 247.5 pg/mL | Standard Deviation 238.1 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 47 | 240.2 pg/mL | Standard Deviation 162.5 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 7 | 242.2 pg/mL | Standard Deviation 172.47 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 49 | 294.5 pg/mL | Standard Deviation 213.57 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 53 | 281.4 pg/mL | Standard Deviation 221.18 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 51 | 283.0 pg/mL | Standard Deviation 212.41 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 15 | 357.4 pg/mL | Standard Deviation 243.67 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Baseline | 519.7 pg/mL | Standard Deviation 191 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 45 | 204.3 pg/mL | Standard Deviation 96.7 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 43 | 246.2 pg/mL | Standard Deviation 105.05 |
| Paricalcitol 4 µg ± 2 µg | Change in Mean iPTH | Week 41 | 242.4 pg/mL | Standard Deviation 115.27 |
Secondary
Duration of 2 Consecutive Decreases in iPTH >= 50%
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Duration of 2 Consecutive Decreases in iPTH >= 50% | 60.6 days | Standard Deviation 94.13 |
| Paricalcitol 2 µg ± 2 µg | Duration of 2 Consecutive Decreases in iPTH >= 50% | 38.8 days | Standard Deviation 34.51 |
| Paricalcitol 4 µg ± 1 µg | Duration of 2 Consecutive Decreases in iPTH >= 50% | 47.2 days | Standard Deviation 62.98 |
| Paricalcitol 4 µg ± 2 µg | Duration of 2 Consecutive Decreases in iPTH >= 50% | 30.2 days | Standard Deviation 32.52 |
Secondary
Duration of 2 Consecutive iPTH Values <= 180 pg/mL
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Duration of 2 Consecutive iPTH Values <= 180 pg/mL | 35.1 days | Standard Deviation 50.58 |
| Paricalcitol 2 µg ± 2 µg | Duration of 2 Consecutive iPTH Values <= 180 pg/mL | 29.2 days | Standard Deviation 20.15 |
| Paricalcitol 4 µg ± 1 µg | Duration of 2 Consecutive iPTH Values <= 180 pg/mL | 28.2 days | Standard Deviation 24.35 |
| Paricalcitol 4 µg ± 2 µg | Duration of 2 Consecutive iPTH Values <= 180 pg/mL | 20.7 days | Standard Deviation 33.43 |
Secondary
The Mean Change in Intact Parathyroid Hormone (iPTH)
Time frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Mean Change in Intact Parathyroid Hormone (iPTH) | -263.7 picograms/milliliter (pg/mL) |
| Paricalcitol 2 µg ± 2 µg | The Mean Change in Intact Parathyroid Hormone (iPTH) | -223.3 picograms/milliliter (pg/mL) |
| Paricalcitol 4 µg ± 1 µg | The Mean Change in Intact Parathyroid Hormone (iPTH) | -248.3 picograms/milliliter (pg/mL) |
| Paricalcitol 4 µg ± 2 µg | The Mean Change in Intact Parathyroid Hormone (iPTH) | -173.3 picograms/milliliter (pg/mL) |
Secondary
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | 66.7 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | 50.0 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | 50.0 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | 42.9 Percentage of participants |
Secondary
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | 50.0 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | 80.0 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | 50.0 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | 72.7 Percentage of participants |
Secondary
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
Time frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | 100.0 Percentage of Participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | 100.0 Percentage of Participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | 100.0 Percentage of Participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | 96.2 Percentage of Participants |
Secondary
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with iPTH <= 180 pg/mL | 42.3 Percentage of participants |
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with decrease in iPTH >= 50% | 57.7 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with iPTH <= 180 pg/mL | 41.4 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with decrease in iPTH >= 50% | 51.7 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with decrease in iPTH >= 50% | 56.5 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with iPTH <= 180 pg/mL | 39.1 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with decrease in iPTH >= 50% | 57.7 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | Subjects with iPTH <= 180 pg/mL | 38.5 Percentage of participants |
Other Pre-specified
The Percentage of Participants With Hypercalcemia
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)
Time frame: Anytime from Week 13 through Week 53
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | The Percentage of Participants With Hypercalcemia | 22.22 Percentage of participants |
| Paricalcitol 2 µg ± 2 µg | The Percentage of Participants With Hypercalcemia | 43.30 Percentage of participants |
| Paricalcitol 4 µg ± 1 µg | The Percentage of Participants With Hypercalcemia | 30.43 Percentage of participants |
| Paricalcitol 4 µg ± 2 µg | The Percentage of Participants With Hypercalcemia | 46.15 Percentage of participants |