An observational study in Kidney Failure, Chronic, sponsored by AbbVie (prior sponsor, Abbott). Completed at 11 sites in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-18.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
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.
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 60 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
Exclusion Criteria:
Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
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
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
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
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
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
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
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
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
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
| Milestone | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Started | 60 |
| Completed | 52 |
| Not completed | 8 |
| Withdrew: Adverse event | 5 |
| Withdrew: Underwent kidney transplantation | 2 |
| Withdrew: Reason not reported | 1 |
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.
| weeks | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) | 12.2 ± 7.6 |
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.
| participants | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 | 14 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
| participants | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy | 5 |
Hypercalcaemia (serum calcium \> 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
| participants | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 20 |
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).
| participants | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy | 39 |
Hyperphosphataemia (serum phosphorus \> 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
| participants | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | 50 |
Collected over Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| End-stage Kidney Disease With Secondary Hyperparathyroidism | — | 9/60 (15%) | 16/60 (26.7%) |
| Event | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| PneumoniaInfections and infestations | 2/60 |
| SepsisInfections and infestations | 2/60 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/60 |
| AnaemiaBlood and lymphatic system disorders | 1/60 |
| Atrial fibrillationCardiac disorders | 1/60 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 1/60 |
| Gastric ulcer haemorrhageGastrointestinal disorders | 1/60 |
| InflammationGeneral disorders | 1/60 |
| PyrexiaGeneral disorders | 1/60 |
| Spinal painGeneral disorders | 1/60 |
| Event | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| HypercalcaemiaMetabolism and nutrition disorders | 7/60 |
| Calcium phosphate product increasedInvestigations | 5/60 |
| HyperphoshataemiaMetabolism and nutrition disorders | 4/60 |
| Age Continuous(years) | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Mean | 57.7 (31 to 86) |
| Sex: Female, Male(Participants) | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Female | 31 |
| Male | 29 |
| Region of Enrollment(participants) | End-stage Kidney Disease With Secondary Hyperparathyroidism |
|---|---|
| Hungary | 60 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott)