Hemodialysis, Hypercalcemia, Parathyroid Hormone, Renal Insufficiency, Chronic, Secondary Hyperparathyroidism
Conditions
Brief summary
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.
Detailed description
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
Interventions
DRUGZemplar (paricalcitol)
Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
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 old with secondary hyperparathyroidism (PTH\>300pg/mL, measured in the last 2 weeks). * Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo). * Patients attending 3 hemodialysis sessions per week. * Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations. * The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.
Exclusion criteria
* Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response. * Patients with severe hyperparathyroidism (PTH\>3000pg/mL). * Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study). * Patients with neoplastic disease. * Pregnant or lactating women. * Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product. * Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study. * Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL | 24 weeks | The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL | 24 Weeks | Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL. |
| Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). | 24 Weeks | The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study. |
Countries
Peru
Participant flow
Pre-assignment details
A total of 114 participants were screened. Of those, 100 participants were enrolled and received at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Injection Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Patient Noncompliance | 6 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Paricalcitol Injection |
|---|---|
| Age Continuous | 46 years STANDARD_DEVIATION 12 |
| Region of Enrollment Peru | 100 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 100 |
| serious Total, serious adverse events | 15 / 100 |
Outcome results
Primary
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
Time frame: 24 weeks
Population: Analysis is based on the number of participants completing the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol Injection | The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL | 96.6 Percentage of participants |
Secondary
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).
The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.
Time frame: 24 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol Injection | Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). | Hypercalcemia | 38 Number of participants |
| Paricalcitol Injection | Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). | Hyperphosphatemia | 33 Number of participants |
| Paricalcitol Injection | Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). | Elevation of Ca x P product | 31 Number of participants |
Secondary
Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL
Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.
Time frame: 24 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paricalcitol Injection | Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL | 4 Weeks |