Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
- Conditions
- Chronic Kidney DiseaseSecondary Hyperparathyroidism
- Registration Number
- NCT01224782
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve \> 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.
- Detailed Description
This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 994
- Patients 18 years of age or older
- Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
- Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/mL and with chronic kidney disease (CKD) stage 4
- Patients clinically indicated for treatment with Zemplar capsules
- Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed
- Patients with clinically important hypercalcemia = Calcium > 2.6 mmol/L (10.5 mg/dL)
- Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values From Baseline up to 12 Months Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 From Baseline up to 12 Months The percentage of participants with Calcium x Phosphorus Product (CxP) values \> 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) From Baseline up to 12 Months The percentage of participants with a decrease in iPTH levels \> 30% at any timepoint during followup, up to 12 months.
Percentage of Participants With Hypercalcemia From Baseline up to 12 months The percentage of participants with hypercalcemia (Calcium \> 2.6 mmol/L \[10.5 mg/dL\]) at any timepoint during followup, up to 12 months.
Mean Weekly Dose of Zemplar (Paricalcitol) From Baseline up to 12 months Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
Number of Participants With Adverse Events (AEs) Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months) An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.
Trial Locations
- Locations (69)
Site Reference ID/Investigator# 66542
🇧🇬Sofia, Bulgaria
Site Reference ID/Investigator# 47684
🇧🇬Sofia, Bulgaria
Site Reference ID/Investigator# 63623
🇷🇴Cluj-Napoca, Romania
Site Reference ID/Investigator# 42995
🇷🇴Timisoara, Romania
Site Reference ID/Investigator# 43453
🇨🇿Ostrava, Czech Republic
Site Reference ID/Investigator# 51008
🇨🇿Prague 10, Czech Republic
Site Reference ID/Investigator# 68462
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 51011
🇨🇿Prague 9, Czech Republic
Site Reference ID/Investigator# 46743
🇨🇿Plzen, Czech Republic
Site Reference ID/Investigator# 47842
🇨🇿Prague 1, Czech Republic
Site Reference ID/Investigator# 51005
🇨🇿Prague 5, Czech Republic
Site Reference ID/Investigator# 42973
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42975
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42970
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42877
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42989
🇷🇴Iasi, Romania
Site Reference ID/Investigator# 43449
🇨🇿Beroun, Czech Republic
Site Reference ID/Investigator# 46744
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 51004
🇨🇿Marianske Lazne, Czech Republic
Site Reference ID/Investigator# 43524
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 48210
🇨🇿Prerov, Czech Republic
Site Reference ID/Investigator# 42992
🇷🇴Bacau, Romania
Site Reference ID/Investigator# 42879
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42882
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42883
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42981
🇷🇴Cluj-Napoca, Romania
Site Reference ID/Investigator# 42982
🇷🇴Cluj-Napoca, Romania
Site Reference ID/Investigator# 43002
🇷🇴Craiova, Romania
Site Reference ID/Investigator# 43000
🇷🇴Oradea, Romania
Site Reference ID/Investigator# 43523
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 45483
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 51009
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 51002
🇨🇿Sokolov, Czech Republic
Site Reference ID/Investigator# 42963
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42878
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42976
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 42999
🇷🇴Oradea, Romania
Site Reference ID/Investigator# 42994
🇷🇴Timisoara, Romania
Site Reference ID/Investigator# 42985
🇷🇴Targu Mures, Romania
Site Reference ID/Investigator# 42987
🇷🇴Targu Mures, Romania
Site Reference ID/Investigator# 66544
🇧🇬Montana, Bulgaria
Site Reference ID/Investigator# 43522
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 47685
🇧🇬Pleven, Bulgaria
Site Reference ID/Investigator# 47683
🇧🇬Sofia, Bulgaria
Site Reference ID/Investigator# 66543
🇧🇬Sofia, Bulgaria
Site Reference ID/Investigator# 66545
🇧🇬Sofia, Bulgaria
Site Reference ID/Investigator# 73353
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 47690
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 47687
🇧🇬Varna, Bulgaria
Site Reference ID/Investigator# 46742
🇨🇿Budejovice, Czech Republic
Site Reference ID/Investigator# 49542
🇨🇿Frydek-Mistek, Czech Republic
Site Reference ID/Investigator# 67442
🇨🇿Jilemnice, Czech Republic
Site Reference ID/Investigator# 67443
🇨🇿Jilemnice, Czech Republic
Site Reference ID/Investigator# 51003
🇨🇿Karlovy Vary, Czech Republic
Site Reference ID/Investigator# 45485
🇨🇿Vyskov, Czech Republic
Site Reference ID/Investigator# 42880
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 45487
🇨🇿Rakovnik, Czech Republic
Site Reference ID/Investigator# 51012
🇨🇿Slany, Czech Republic
Site Reference ID/Investigator# 42881
🇷🇴Bucharest, Romania
Site Reference ID/Investigator# 43448
🇨🇿Trutnov, Czech Republic
Site Reference ID/Investigator# 42980
🇷🇴Cluj-Napoca, Romania
Site Reference ID/Investigator# 43009
🇷🇴Constanta, Romania
Site Reference ID/Investigator# 43003
🇷🇴Craiova, Romania
Site Reference ID/Investigator# 42991
🇷🇴Iasi, Romania
Site Reference ID/Investigator# 42979
🇷🇴Ploiesti, Romania
Site Reference ID/Investigator# 42984
🇷🇴Targu Mures, Romania
Site Reference ID/Investigator# 42988
🇷🇴Iasi, Romania
Site Reference ID/Investigator# 43006
🇷🇴Craiova, Romania
Site Reference ID/Investigator# 66546
🇧🇬Plovdiv, Bulgaria