Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

Chronic Kidney Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224782
• Other study ID #: P12-269
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: September 12, 2014
• Start date: October 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeBulgaria: Ethics committeeCzech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 66544	Montana
Bulgaria	Site Reference ID/Investigator# 47685	Pleven
Bulgaria	Site Reference ID/Investigator# 66546	Plovdiv
Bulgaria	Site Reference ID/Investigator# 47683	Sofia
Bulgaria	Site Reference ID/Investigator# 47684	Sofia
Bulgaria	Site Reference ID/Investigator# 66542	Sofia
Bulgaria	Site Reference ID/Investigator# 66543	Sofia
Bulgaria	Site Reference ID/Investigator# 66545	Sofia
Bulgaria	Site Reference ID/Investigator# 47687	Varna
Czech Republic	Site Reference ID/Investigator# 43449	Beroun
Czech Republic	Site Reference ID/Investigator# 46744	Brno
Czech Republic	Site Reference ID/Investigator# 47690	Brno
Czech Republic	Site Reference ID/Investigator# 73353	Brno
Czech Republic	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# 51004	Marianske Lazne
Czech Republic	Site Reference ID/Investigator# 43522	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 43523	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 43524	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 45483	Olomouc
Czech Republic	Site Reference ID/Investigator# 43453	Ostrava
Czech Republic	Site Reference ID/Investigator# 46743	Plzen
Czech Republic	Site Reference ID/Investigator# 47842	Prague 1
Czech Republic	Site Reference ID/Investigator# 51008	Prague 10
Czech Republic	Site Reference ID/Investigator# 51009	Prague 4
Czech Republic	Site Reference ID/Investigator# 68462	Prague 4
Czech Republic	Site Reference ID/Investigator# 51005	Prague 5
Czech Republic	Site Reference ID/Investigator# 51011	Prague 9
Czech Republic	Site Reference ID/Investigator# 48210	Prerov
Czech Republic	Site Reference ID/Investigator# 45487	Rakovnik
Czech Republic	Site Reference ID/Investigator# 51012	Slany
Czech Republic	Site Reference ID/Investigator# 51002	Sokolov
Czech Republic	Site Reference ID/Investigator# 43448	Trutnov
Czech Republic	Site Reference ID/Investigator# 45485	Vyskov
Romania	Site Reference ID/Investigator# 42992	Bacau
Romania	Site Reference ID/Investigator# 42877	Bucharest
Romania	Site Reference ID/Investigator# 42878	Bucharest
Romania	Site Reference ID/Investigator# 42879	Bucharest
Romania	Site Reference ID/Investigator# 42880	Bucharest
Romania	Site Reference ID/Investigator# 42881	Bucharest
Romania	Site Reference ID/Investigator# 42882	Bucharest
Romania	Site Reference ID/Investigator# 42883	Bucharest
Romania	Site Reference ID/Investigator# 42963	Bucharest
Romania	Site Reference ID/Investigator# 42970	Bucharest
Romania	Site Reference ID/Investigator# 42973	Bucharest
Romania	Site Reference ID/Investigator# 42975	Bucharest
Romania	Site Reference ID/Investigator# 42976	Bucharest
Romania	Site Reference ID/Investigator# 42980	Cluj-Napoca
Romania	Site Reference ID/Investigator# 42981	Cluj-Napoca
Romania	Site Reference ID/Investigator# 42982	Cluj-Napoca
Romania	Site Reference ID/Investigator# 63623	Cluj-Napoca
Romania	Site Reference ID/Investigator# 43009	Constanta
Romania	Site Reference ID/Investigator# 43002	Craiova
Romania	Site Reference ID/Investigator# 43003	Craiova
Romania	Site Reference ID/Investigator# 43006	Craiova
Romania	Site Reference ID/Investigator# 42988	Iasi
Romania	Site Reference ID/Investigator# 42989	Iasi
Romania	Site Reference ID/Investigator# 42991	Iasi
Romania	Site Reference ID/Investigator# 42999	Oradea
Romania	Site Reference ID/Investigator# 43000	Oradea
Romania	Site Reference ID/Investigator# 42979	Ploiesti
Romania	Site Reference ID/Investigator# 42984	Targu Mures
Romania	Site Reference ID/Investigator# 42985	Targu Mures
Romania	Site Reference ID/Investigator# 42987	Targu Mures
Romania	Site Reference ID/Investigator# 42994	Timisoara
Romania	Site Reference ID/Investigator# 42995	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values	Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).	From Baseline up to 12 Months	No
Primary	Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg^2/dL^2 or 5.24 mmol^2/L^2	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.	From Baseline up to 12 Months	No
Secondary	Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)	The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.	From Baseline up to 12 Months	No
Secondary	Percentage of Participants With Hypercalcemia	The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.	From Baseline up to 12 months	Yes
Secondary	Mean Weekly Dose of Zemplar (Paricalcitol)	Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).	From Baseline up to 12 months	No
Secondary	Number of Participants With Adverse Events (AEs)	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.	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)	Yes

External Links

•   Link