Kidney Failure, Chronic
Conditions
Keywords
Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary
Brief summary
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
Detailed description
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
Interventions
None listed
Sponsors
Planimeter Ltd
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
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and: 1. ≥ 18 years of age, 2. Willing to sign the patient information and informed consent form, 3. Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is: * between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. \> 2.4 mmol/L) in the medical history, or * higher than 800 pg/mL and parathyroidectomy is contraindicated. 4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
Exclusion criteria
Patients cannot be enrolled in the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) | 6 months | Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance | 6 months prior to start of study through 6 months of treatment | If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical \[ATC\] group A11CC \[vitamin D and analogues\]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. |
| Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance | 6 months prior to start of study through 6 months of treatment | If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. |
| Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism | 6 months prior to start of study through 6 months of treatment | If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. |
| Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 | 6 months | Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. |
| Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 6 months | Hypercalcaemia (serum calcium \> 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). |
| Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy | 6 months prior to start of study through baseline | Hyperphosphataemia (serum phosphorus \>1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). |
| Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 6 months | Hyperphosphataemia (serum phosphorus \> 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). |
| Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy | 6 months prior to start of study through baseline | Hypercalcaemia (serum calcium \> 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT) | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Reason Not Reported | 1 |
| Overall Study | Underwent Kidney Transplantation | 2 |
Baseline characteristics
| Characteristic | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Age Continuous | 57.7 years |
| Region of Enrollment Hungary | 60 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 60 |
| serious Total, serious adverse events | 9 / 60 |
Outcome results
Primary
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Time frame: 6 months
Population: Participants who achieved maintenance dose of Zemplar (paricalcitol injection)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) | 12.2 weeks | Standard Deviation 7.6 |
Secondary
Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical \[ATC\] group A11CC \[vitamin D and analogues\]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time frame: 6 months prior to start of study through 6 months of treatment
Population: This outcome measure was not analyzed due to lack of data.
Secondary
Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time frame: 6 months prior to start of study through 6 months of treatment
Population: This outcome measure was not analyzed due to lack of data.
Secondary
Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time frame: 6 months prior to start of study through 6 months of treatment
Population: This outcome measure was not analyzed due to lack of data.
Secondary
Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Time frame: 6 months
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 | 14 participants |
Secondary
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hypercalcaemia (serum calcium \> 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Time frame: 6 months
Population: Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 20 participants |
Secondary
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Hypercalcaemia (serum calcium \> 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Time frame: 6 months prior to start of study through baseline
Population: Participants with available retrospective data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy | 5 participants |
Secondary
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hyperphosphataemia (serum phosphorus \> 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Time frame: 6 months
Population: Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 50 participants |
Secondary
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Hyperphosphataemia (serum phosphorus \>1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Time frame: 6 months prior to start of study through baseline
Population: Participants with available retrospective data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy | 39 participants |