Clinical trial NCT01224782: Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
Official title: Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Keywords: Zemplar capsules
Chronic kidney disease (CKD) stage 3 or 4
Secondary hyperparathyroidism (SHPT)
Postmarketing observational study (PMOS)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Zemplar capsules will be prescribed in usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Zemplar capsules would be made prior to entry of a subject in the study.

Medical doctors with experience in treatment of patients with chronic kidney disease (CKD) stage 3 or 4 and secondary hyperparathyroidism (SHPT) will observe each enrolled patient for a period of 12 months.

Follow-up of patients should enable 6 patient visits during this period.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
timeFrame: From Baseline up to 12 Months
measure: Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
timeFrame: From Baseline up to 12 Months
Secondary outcomes:
measure: Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
timeFrame: From Baseline up to 12 Months
measure: Percentage of Participants With Hypercalcemia
timeFrame: From Baseline up to 12 months
measure: Mean Weekly Dose of Zemplar (Paricalcitol)
timeFrame: From Baseline up to 12 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Montana
country: Bulgaria
facility: Site Reference ID/Investigator# 66544
city: Pleven
country: Bulgaria
facility: Site Reference ID/Investigator# 47685
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 66546
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 47683
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 66543
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 47684
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 66542
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 66545
city: Varna
country: Bulgaria
facility: Site Reference ID/Investigator# 47687
city: Beroun
country: Czech Republic
facility: Site Reference ID/Investigator# 43449
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 46744
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 73353
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 47690
city: Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 46742
city: Frydek-Mistek
country: Czech Republic
facility: Site Reference ID/Investigator# 49542
city: Jilemnice
country: Czech Republic
facility: Site Reference ID/Investigator# 67442
city: Jilemnice
country: Czech Republic
facility: Site Reference ID/Investigator# 67443
city: Karlovy Vary
country: Czech Republic
facility: Site Reference ID/Investigator# 51003
city: Marianske Lazne
country: Czech Republic
facility: Site Reference ID/Investigator# 51004
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 43522
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 43523
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 43524
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 45483
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 43453
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 46743
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 51008
city: Prague 1
country: Czech Republic
facility: Site Reference ID/Investigator# 47842
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 68462
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 51009
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 51005
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 51011
city: Prerov
country: Czech Republic
facility: Site Reference ID/Investigator# 48210
city: Rakovnik
country: Czech Republic
facility: Site Reference ID/Investigator# 45487
city: Slany
country: Czech Republic
facility: Site Reference ID/Investigator# 51012
city: Sokolov
country: Czech Republic
facility: Site Reference ID/Investigator# 51002
city: Trutnov
country: Czech Republic
facility: Site Reference ID/Investigator# 43448
city: Vyskov
country: Czech Republic
facility: Site Reference ID/Investigator# 45485
city: Bacau
country: Romania
facility: Site Reference ID/Investigator# 42992
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42879
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42880
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42881
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42882
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42883
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42963
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42970
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42877
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42878
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42973
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42975
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 42976
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 42981
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 42982
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 42980
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 63623
city: Constanta
country: Romania
facility: Site Reference ID/Investigator# 43009
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 43002
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 43003
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 43006
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 42991
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 42988
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 42989
city: Oradea
country: Romania
facility: Site Reference ID/Investigator# 42999
city: Oradea
country: Romania
facility: Site Reference ID/Investigator# 43000
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 42979
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 42984
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 42985
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 42987
city: Timisoara
country: Romania
facility: Site Reference ID/Investigator# 42994
city: Timisoara
country: Romania
facility: Site Reference ID/Investigator# 42995
Study officials:
affiliation: AbbVie
name: Corina Ionescu, MD
role: STUDY_DIRECTOR
References: