Kidney Insufficiency, Secondary Hyperparathyroidism
Conditions
Keywords
Observational study, Paricalcitol, Treatment of Hyperparathyroidism, Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5), Chronic Kidney Disease, Zemplar, sHPT, Secondary
Brief summary
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
Detailed description
According to protocol amendment of 16 October 2010 Austria is participating in this study. Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis. Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare. Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease * Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study
Exclusion criteria
* The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply * An additional exclusion criterion is a parathyroid hormone- value of \> 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Up to 12 Months | Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL). |
| Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Up to 12 months | Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Elevated Calcium-Phosphorus Product | Months 0, 3, 6, 9, and 12 | Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit. |
| Mean Duration of Hospitalization by Visit | Months 0, 3, 6, 9, and 11 | — |
| Number of Participants With Hypercalcemia | Months 0, 3, 6, 9, and 12 | Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit. |
| Mean Intact Parathormone (iPTH) Levels by Visit | Months 0, 3, 6, 9, and 12 | — |
| Mean Calcium-Phosphate Product Levels by Visit | Months 0, 3, 6, 9, and 12 | — |
| Mean Duration of Disability by Visit | Months 0, 3, 6, 9, and 11 | — |
| Number of Participants With Hyperphosphatemia | Months 0, 3, 6, 9, and 12 | Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit. |
Countries
Austria, Germany
Participant flow
Pre-assignment details
761 participants were enrolled in the study, but two participants lacked information necessary for assignment to one of the analysis groups (pre-dialysis or dialysis). Hence, analysis was conducted with 759 participants.
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Pre-dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. | 121 |
| Paricalcitol Dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. | 638 |
| Total | 759 |
Baseline characteristics
| Characteristic | Paricalcitol Dialysis Group | Total | Paricalcitol Pre-dialysis Group |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 14.9 | 62.8 years STANDARD_DEVIATION 14.8 | 64.2 years STANDARD_DEVIATION 13.9 |
| Duration of Chronic Kidney Disease | 71.2 months STANDARD_DEVIATION 61.1 | 67.5 months STANDARD_DEVIATION 59.6 | 39.3 months STANDARD_DEVIATION 36 |
| Duration of Secondary Hyperparathyroidism | 43.9 months STANDARD_DEVIATION 36.6 | 39.5 months STANDARD_DEVIATION 35.8 | 17.7 months STANDARD_DEVIATION 20.6 |
| Sex: Female, Male Female | 291 Participants | 338 Participants | 47 Participants |
| Sex: Female, Male Male | 347 Participants | 421 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 637 |
| serious Total, serious adverse events | 16 / 96 | 186 / 637 |
Outcome results
Primary
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
Time frame: Up to 12 Months
Population: Participants with a determined chronic kidney disease (CKD) stage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 3 [N=56] | 30.4 percentage of participants |
| Paricalcitol | Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 4 [N=82] | 30.5 percentage of participants |
| Paricalcitol | Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 5 [N=580] | 70.2 percentage of participants |
Primary
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
Time frame: Up to 12 months
Population: Participants with a determined chronic kidney disease (CKD) stage
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 3 [N=17] | 212.4 days | Standard Deviation 203.93 |
| Paricalcitol | Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 4 [N=25] | 195.5 days | Standard Deviation 118.3 |
| Paricalcitol | Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Stage 5 [N=407] | 145.7 days | Standard Deviation 107.1 |
Secondary
Mean Calcium-Phosphate Product Levels by Visit
Time frame: Months 0, 3, 6, 9, and 12
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Calcium-Phosphate Product Levels by Visit | Month 3 | 3.50 mmol²/l² | Standard Deviation 1.46 |
| Paricalcitol | Mean Calcium-Phosphate Product Levels by Visit | Month 9 | 3.61 mmol²/l² | Standard Deviation 1.37 |
| Paricalcitol | Mean Calcium-Phosphate Product Levels by Visit | Month 6 | 3.62 mmol²/l² | Standard Deviation 1.61 |
| Paricalcitol | Mean Calcium-Phosphate Product Levels by Visit | Month 12 | 3.48 mmol²/l² | Standard Deviation 1.2 |
| Paricalcitol | Mean Calcium-Phosphate Product Levels by Visit | Month 0 | 3.32 mmol²/l² | Standard Deviation 3.12 |
| Paricalcitol Dialysis Group | Mean Calcium-Phosphate Product Levels by Visit | Month 12 | 4.21 mmol²/l² | Standard Deviation 1.31 |
| Paricalcitol Dialysis Group | Mean Calcium-Phosphate Product Levels by Visit | Month 0 | 4.12 mmol²/l² | Standard Deviation 1.29 |
| Paricalcitol Dialysis Group | Mean Calcium-Phosphate Product Levels by Visit | Month 3 | 4.30 mmol²/l² | Standard Deviation 1.26 |
| Paricalcitol Dialysis Group | Mean Calcium-Phosphate Product Levels by Visit | Month 6 | 4.32 mmol²/l² | Standard Deviation 1.22 |
| Paricalcitol Dialysis Group | Mean Calcium-Phosphate Product Levels by Visit | Month 9 | 4.25 mmol²/l² | Standard Deviation 1.29 |
Secondary
Mean Duration of Disability by Visit
Time frame: Months 0, 3, 6, 9, and 11
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Duration of Disability by Visit | Month 6 | 0.0 days | Standard Deviation 0 |
| Paricalcitol | Mean Duration of Disability by Visit | Month 11 | 0.3 days | Standard Deviation 1 |
| Paricalcitol | Mean Duration of Disability by Visit | Month 9 | 0.0 days | Standard Deviation 0 |
| Paricalcitol | Mean Duration of Disability by Visit | Month 0 | 0.0 days | Standard Deviation 0 |
| Paricalcitol | Mean Duration of Disability by Visit | Month 3 | 4.7 days | Standard Deviation 8.1 |
| Paricalcitol Dialysis Group | Mean Duration of Disability by Visit | Month 0 | 0.3 days | Standard Deviation 3 |
| Paricalcitol Dialysis Group | Mean Duration of Disability by Visit | Month 3 | 0.2 days | Standard Deviation 2 |
| Paricalcitol Dialysis Group | Mean Duration of Disability by Visit | Month 6 | 0.4 days | Standard Deviation 3.5 |
| Paricalcitol Dialysis Group | Mean Duration of Disability by Visit | Month 9 | 0.4 days | Standard Deviation 3.1 |
| Paricalcitol Dialysis Group | Mean Duration of Disability by Visit | Month 11 | 0.4 days | Standard Deviation 3.2 |
Secondary
Mean Duration of Hospitalization by Visit
Time frame: Months 0, 3, 6, 9, and 11
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Duration of Hospitalization by Visit | Month 3 | 1.8 days | Standard Deviation 4.4 |
| Paricalcitol | Mean Duration of Hospitalization by Visit | Month 9 | 0.0 days | Standard Deviation 0 |
| Paricalcitol | Mean Duration of Hospitalization by Visit | Month 6 | 2.9 days | Standard Deviation 5.9 |
| Paricalcitol | Mean Duration of Hospitalization by Visit | Month 11 | 0.9 days | Standard Deviation 4 |
| Paricalcitol | Mean Duration of Hospitalization by Visit | Month 0 | 1.3 days | Standard Deviation 4.9 |
| Paricalcitol Dialysis Group | Mean Duration of Hospitalization by Visit | Month 11 | 0.6 days | Standard Deviation 3.9 |
| Paricalcitol Dialysis Group | Mean Duration of Hospitalization by Visit | Month 0 | 0.7 days | Standard Deviation 4 |
| Paricalcitol Dialysis Group | Mean Duration of Hospitalization by Visit | Month 3 | 0.8 days | Standard Deviation 3.5 |
| Paricalcitol Dialysis Group | Mean Duration of Hospitalization by Visit | Month 6 | 0.8 days | Standard Deviation 4.3 |
| Paricalcitol Dialysis Group | Mean Duration of Hospitalization by Visit | Month 9 | 0.8 days | Standard Deviation 3.5 |
Secondary
Mean Intact Parathormone (iPTH) Levels by Visit
Time frame: Months 0, 3, 6, 9, and 12
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Intact Parathormone (iPTH) Levels by Visit | Month 6 | 23.01 pmol/L | Standard Deviation 27.32 |
| Paricalcitol | Mean Intact Parathormone (iPTH) Levels by Visit | Month 9 | 27.85 pmol/L | Standard Deviation 33.95 |
| Paricalcitol | Mean Intact Parathormone (iPTH) Levels by Visit | Month 3 | 26.95 pmol/L | Standard Deviation 36.94 |
| Paricalcitol | Mean Intact Parathormone (iPTH) Levels by Visit | Month 12 | 29.57 pmol/L | Standard Deviation 31.28 |
| Paricalcitol | Mean Intact Parathormone (iPTH) Levels by Visit | Month 0 | 29.65 pmol/L | Standard Deviation 26.95 |
| Paricalcitol Dialysis Group | Mean Intact Parathormone (iPTH) Levels by Visit | Month 12 | 38.24 pmol/L | Standard Deviation 33.76 |
| Paricalcitol Dialysis Group | Mean Intact Parathormone (iPTH) Levels by Visit | Month 0 | 54.85 pmol/L | Standard Deviation 29.51 |
| Paricalcitol Dialysis Group | Mean Intact Parathormone (iPTH) Levels by Visit | Month 3 | 37.20 pmol/L | Standard Deviation 28.35 |
| Paricalcitol Dialysis Group | Mean Intact Parathormone (iPTH) Levels by Visit | Month 6 | 37.18 pmol/L | Standard Deviation 30.08 |
| Paricalcitol Dialysis Group | Mean Intact Parathormone (iPTH) Levels by Visit | Month 9 | 36.54 pmol/L | Standard Deviation 29.42 |
Secondary
Number of Participants With Elevated Calcium-Phosphorus Product
Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.
Time frame: Months 0, 3, 6, 9, and 12
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Number of Participants With Elevated Calcium-Phosphorus Product | Month 3 | 6 participants |
| Paricalcitol | Number of Participants With Elevated Calcium-Phosphorus Product | Month 9 | 6 participants |
| Paricalcitol | Number of Participants With Elevated Calcium-Phosphorus Product | Month 6 | 7 participants |
| Paricalcitol | Number of Participants With Elevated Calcium-Phosphorus Product | Month 12 | 4 participants |
| Paricalcitol | Number of Participants With Elevated Calcium-Phosphorus Product | Month 0 | 5 participants |
| Paricalcitol Dialysis Group | Number of Participants With Elevated Calcium-Phosphorus Product | Month 12 | 78 participants |
| Paricalcitol Dialysis Group | Number of Participants With Elevated Calcium-Phosphorus Product | Month 0 | 102 participants |
| Paricalcitol Dialysis Group | Number of Participants With Elevated Calcium-Phosphorus Product | Month 3 | 97 participants |
| Paricalcitol Dialysis Group | Number of Participants With Elevated Calcium-Phosphorus Product | Month 6 | 101 participants |
| Paricalcitol Dialysis Group | Number of Participants With Elevated Calcium-Phosphorus Product | Month 9 | 89 participants |
Secondary
Number of Participants With Hypercalcemia
Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.
Time frame: Months 0, 3, 6, 9, and 12
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Number of Participants With Hypercalcemia | Month 3 | 2 participants |
| Paricalcitol | Number of Participants With Hypercalcemia | Month 9 | 1 participants |
| Paricalcitol | Number of Participants With Hypercalcemia | Month 6 | 1 participants |
| Paricalcitol | Number of Participants With Hypercalcemia | Month 12 | 1 participants |
| Paricalcitol | Number of Participants With Hypercalcemia | Month 0 | 1 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hypercalcemia | Month 12 | 5 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hypercalcemia | Month 0 | 2 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hypercalcemia | Month 3 | 6 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hypercalcemia | Month 6 | 4 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hypercalcemia | Month 9 | 4 participants |
Secondary
Number of Participants With Hyperphosphatemia
Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.
Time frame: Months 0, 3, 6, 9, and 12
Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Number of Participants With Hyperphosphatemia | Month 3 | 8 participants |
| Paricalcitol | Number of Participants With Hyperphosphatemia | Month 9 | 9 participants |
| Paricalcitol | Number of Participants With Hyperphosphatemia | Month 6 | 8 participants |
| Paricalcitol | Number of Participants With Hyperphosphatemia | Month 12 | 8 participants |
| Paricalcitol | Number of Participants With Hyperphosphatemia | Month 0 | 5 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hyperphosphatemia | Month 12 | 128 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hyperphosphatemia | Month 0 | 192 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hyperphosphatemia | Month 3 | 153 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hyperphosphatemia | Month 6 | 151 participants |
| Paricalcitol Dialysis Group | Number of Participants With Hyperphosphatemia | Month 9 | 133 participants |