Dialysis, Secondary Hyperparathyroidism
Conditions
Keywords
Dialysis, Hyperparathyroidism, Zemplar
Brief summary
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.
Interventions
Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>=18 years with secondary hyperparathyroidism (iPTH \>= 300 pg/mL) * Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment * Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator * Patients providing their signed informed consent to participate in the trial
Exclusion criteria
* Patients with severe hyperparathyroidism (iPTH \> 3,000 pg/ml) * Patients with hypercalcaemia (calcium \>=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus \>= 6.5 mg/dl) or patients with calcium x phosphorus \>= 70 * Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients * Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies * Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum * Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | 24 weeks | Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response to Treatment | 24 weeks | Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit. |
| Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | 24 Weeks | Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75. |
| Proportion of Subjects Who Achieve an iPTH <300 pg/mL | 24 weeks | Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL. |
| Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | 24 weeks | Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%. |
| Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Baseline and 24 weeks | Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules. |
Countries
Mexico
Participant flow
Recruitment details
Participants were enrolled into the study at 12 dialysis centers in Mexico. Recruitment began in September 2007 and ended in January 2010. The study population consisted of patients on hemodialysis or peritoneal dialysis with a diagnosis of secondary hyperparathyroidism.
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Injection Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis. | 38 |
| Paricalcitol Capsules Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis. | 109 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Death | 0 | 3 |
| Overall Study | Heart failure | 0 | 1 |
| Overall Study | Kidney transplant | 0 | 3 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Non-compliance with treatment/procedure | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Paricalcitol Injection | Paricalcitol Capsules | Total |
|---|---|---|---|
| Age Continuous | 43.79 years STANDARD_DEVIATION 16.36 | 44.89 years STANDARD_DEVIATION 17.91 | 44.39 years STANDARD_DEVIATION 17.47 |
| Region of Enrollment Mexico | 38 participants | 109 participants | 147 participants |
| Sex: Female, Male Female | 21 Participants | 50 Participants | 71 Participants |
| Sex: Female, Male Male | 17 Participants | 59 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 38 | 84 / 109 |
| serious Total, serious adverse events | 8 / 38 | 9 / 109 |
Outcome results
Primary
Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.
Time frame: 24 weeks
Population: The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol Injection | Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | 17 participants |
| Paricalcitol Capsules | Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | 57 participants |
Secondary
Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.
Time frame: 24 Weeks
Population: The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol Injection | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Hypercalcemia | 2 participants |
| Paricalcitol Injection | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Hyperphosphatemia | 9 participants |
| Paricalcitol Injection | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Elevated calcium x phosphorus product | 3 participants |
| Paricalcitol Capsules | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Hypercalcemia | 6 participants |
| Paricalcitol Capsules | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Hyperphosphatemia | 19 participants |
| Paricalcitol Capsules | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Elevated calcium x phosphorus product | 14 participants |
Secondary
Duration of Response to Treatment
Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.
Time frame: 24 weeks
Population: The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol Injection | Duration of Response to Treatment | 65.86 days | Standard Deviation 51.39 |
Secondary
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.
Time frame: Baseline and 24 weeks
Population: The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 2 | 7 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 1 | 26 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 1 | 13 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 2 | 4 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 1 | 17 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 1 | 7 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 1 | 21 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 2 | 24 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 3 | 1 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 2 | 11 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 1 | 25 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 2 | 5 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 2 | 4 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 1 | 26 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 1 | 25 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 2 | 7 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 1 | 23 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 1 | 26 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 2 | 15 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 2 | 4 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 2 | 19 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 3 | 0 Participants |
| Paricalcitol Injection | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 3 | 0 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 3 | 0 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 3 | 2 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 1 | 79 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 3 | 0 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 3 | 6 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 1 | 38 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 2 | 47 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Baseline Score 3 | 2 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 1 | 74 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 2 | 14 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Mobility-Final Score 3 | 0 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 1 | 64 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Baseline Score 2 | 21 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Personal Care-Final Score 2 | 9 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 1 | 35 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 2 | 50 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Baseline Score 3 | 3 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 1 | 71 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 2 | 16 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Daily Activities-Final Score 3 | 1 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 1 | 24 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 2 | 55 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Baseline Score 3 | 8 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 1 | 73 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 2 | 15 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Pain/Discomfort-Final Score 3 | 0 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 1 | 34 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Baseline Score 2 | 48 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 1 | 73 Participants |
| Paricalcitol Capsules | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Anxiety/Depression-Final Score 2 | 15 Participants |
Secondary
Proportion of Subjects Who Achieve an iPTH <300 pg/mL
Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.
Time frame: 24 weeks
Population: The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol Injection | Proportion of Subjects Who Achieve an iPTH <300 pg/mL | 16 participants |
| Paricalcitol Capsules | Proportion of Subjects Who Achieve an iPTH <300 pg/mL | 57 participants |
Secondary
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level
Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.
Time frame: 24 weeks
Population: The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol Injection | Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | Time to achieve 50% or greater reduction in iPTH | 48.68 days | Standard Deviation 43.3 |
| Paricalcitol Injection | Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | Time to achieve either | 40.29 days | Standard Deviation 38.13 |
| Paricalcitol Injection | Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | Time to achieve iPTH less than 300 pg/mL | 43.80 days | Standard Deviation 41.43 |