Secondary Hyperparathyroidism
Conditions
Keywords
Secondary Hyperparathyroidism, Chronic Renal Insufficiency
Brief summary
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.
Detailed description
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study. Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar). Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study. The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.
Interventions
None listed
Sponsors
Almedis
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years 2. Chronic Kidney Disease stage 5 receiving hemodialysis 3. Authorization (Consent) for Use/Disclosure of Data signed by the patient 4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program 5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL
Exclusion criteria
1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy 2. Any experimental drug within the period of 30 days before the inclusion into the program 3. Screening Ca x P \> 65 mg˄2/dL˄2 4. Screening normalized serum total calcium \> 10.2 mg/dL 5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study | 6 months | The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | 6 months | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded. |
| Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study | 6 months | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded. |
| Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | 6 months | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded. |
| Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study | 6 months | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded. |
| Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | 6 months | The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at each visit post-baseline during the study was recorded. |
| Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination | 6 months | The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks. |
| Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study | 6 months | The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at least once post-baseline during the study was recorded. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 5 Chronic Kidney Disease Planned for Zemplar administration due to secondary hyperparathyroidism | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Blood samples not available | 1 |
| Overall Study | Hyperphosphatemia | 5 |
| Overall Study | Hyperphosphatemia and adverse event | 1 |
| Overall Study | Kidney transplantation | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Low intact parathyroid hormone | 1 |
| Overall Study | Serious adverse event | 1 |
| Overall Study | Study drug not available | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Stage 5 Chronic Kidney Disease |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants |
| Age, Continuous | 45.4 Participants STANDARD_DEVIATION 12.6 |
| Region of Enrollment Russian Federation | 86 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 86 |
| serious Total, serious adverse events | 3 / 86 |
Outcome results
Primary
The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study
The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 5 Chronic Kidney Disease | The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study | 60.5 Percentage of participants |
Secondary
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 1 | 12.8 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 2 | 16.3 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 3 | 16.3 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 4 | 4.7 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 5 | 7.0 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | Visit 6 | 8.1 Percentage of participants |
Secondary
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study | 38.4 Percentage of participants |
Secondary
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 6 | 0 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 1 | 1.2 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 2 | 2.3 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 3 | 2.3 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 4 | 4.7 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | Visit 5 | 2.3 Percentage of participants |
Secondary
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
The percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at least once post-baseline during the study was recorded.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study | 10.5 Percentage of participants |
Secondary
Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination | Hypercalcemia | 0 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination | Hyperphosphatemia | 7.0 Percentage of participants |
Secondary
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
Time frame: 6 months
Population: The analysis for this outcome was based on the number of participants (55) who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Baseline | 49.1 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 1 | 65.5 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 2 | 45.5 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 3 | 67.3 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 4 | 40.0 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 5 | 41.8 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | Visit 6 | 49.1 Percentage of participants |
Secondary
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study | Baseline | 57.0 Percentage of participants |
| Stage 5 Chronic Kidney Disease | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study | Post-baseline | 87.2 Percentage of participants |