Parathyroid Hormone
Conditions
Keywords
paricalcitol iv, vitamin D, secondary hyperparathyroidism, hemodialysis
Brief summary
This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.
Detailed description
This study is a non-interventional, observational study in which Zemplar® Injection is prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics (SmPC) with regards to dose, population and indication. The study population consists of participants receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral VDR activator (calcitriol or alfacalcidol). Participants will be included via consecutive sampling. To be included, participants should have a clinical indication to initiate treatment with Zemplar® Injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). Each participant will be observed during his/her Zemplar® Injection treatment regimen for a maximum period of 12 months.
Interventions
DRUGZemplar iv (paricalcitol iv)
Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.
Sponsors
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment iPTH \> 300 pg/mL, receiving chronic hemodialysis. * Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Exclusion criteria
* Subject has a corrected serum calcium \>10.5 mg/dL, serum phosphorus \> 6.5 mg/dL or subjects with corrected Ca x P\>65. * Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients, or has participated in clinical study within the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline | Baseline through 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) | Baseline through 12 months | Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit. |
| Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL | Baseline through 12 months | The average time (measured in days) to achieve target iPTH levels. |
| Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements. | Baseline through 12 months | Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study. |
Countries
Croatia, Serbia
Participant flow
Pre-assignment details
Safety population consists of 181 participants who received at least one dose of drug. Of those, 175 were included in the full analysis set. Six participants were excluded; five due to initial intact parathyroid hormone values less than 300 picograms per milliliter and one suffered a serious adverse event before the first evaluation (study visit).
Participants by arm
| Arm | Count |
|---|---|
| End Stage Chronic Kidney Disease Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Change of residence | 2 |
| Overall Study | Drug not available | 30 |
| Overall Study | Hyperphosphatemia | 2 |
| Overall Study | Kidney transplant | 6 |
| Overall Study | Lack of effectiveness | 2 |
| Overall Study | Nodular hyperplasia of parathyroid gland | 2 |
| Overall Study | Over-suppression of parathyroid gland | 2 |
| Overall Study | Patient noncompliance | 2 |
| Overall Study | Reason unknown | 8 |
| Overall Study | Serious Adverse Event | 3 |
Baseline characteristics
| Characteristic | End Stage Chronic Kidney Disease |
|---|---|
| Age Continuous | 55.3 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 181 |
| serious Total, serious adverse events | 15 / 181 |
Outcome results
Primary
Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline
Time frame: Baseline through 12 months
Population: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End Stage Chronic Kidney Disease | Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline | 58.1 percentage of participants |
Secondary
Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.
Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.
Time frame: Baseline through 12 months
Population: Analysis was based on the number of subjects included in the full analysis set (N=175).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End Stage Chronic Kidney Disease | Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements. | 2 participants |
Secondary
Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)
Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
Time frame: Baseline through 12 months
Population: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End Stage Chronic Kidney Disease | Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) | 43.7 percentage of participants |
Secondary
Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL
The average time (measured in days) to achieve target iPTH levels.
Time frame: Baseline through 12 months
Population: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| End Stage Chronic Kidney Disease | Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL | 107.0 Days | Standard Deviation 102.7 |