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

NCT ID: NCT01224782

Last Updated: 2014-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

994 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease Secondary Hyperparathyroidism

Study Groups

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Chronic Kidney Disease, Secondary Hyperparathyroidism

All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corina Ionescu, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 66544

Montana, , Bulgaria

Site Status

Site Reference ID/Investigator# 47685

Pleven, , Bulgaria

Site Status

Site Reference ID/Investigator# 66546

Plovdiv, , Bulgaria

Site Status

Site Reference ID/Investigator# 47683

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 66543

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 47684

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 66542

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 66545

Sofia, , Bulgaria

Site Status

Site Reference ID/Investigator# 47687

Varna, , Bulgaria

Site Status

Site Reference ID/Investigator# 43449

Beroun, , Czechia

Site Status

Site Reference ID/Investigator# 46744

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 73353

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 47690

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 46742

České Budějovice, , Czechia

Site Status

Site Reference ID/Investigator# 49542

Frýdek-Místek, , Czechia

Site Status

Site Reference ID/Investigator# 67442

Jilemnice, , Czechia

Site Status

Site Reference ID/Investigator# 67443

Jilemnice, , Czechia

Site Status

Site Reference ID/Investigator# 51003

Karlovy Vary, , Czechia

Site Status

Site Reference ID/Investigator# 51004

Mariánské Lázně, , Czechia

Site Status

Site Reference ID/Investigator# 43522

Nový Jičín, , Czechia

Site Status

Site Reference ID/Investigator# 43523

Nový Jičín, , Czechia

Site Status

Site Reference ID/Investigator# 43524

Nový Jičín, , Czechia

Site Status

Site Reference ID/Investigator# 45483

Olomouc, , Czechia

Site Status

Site Reference ID/Investigator# 43453

Ostrava, , Czechia

Site Status

Site Reference ID/Investigator# 46743

Pilsen, , Czechia

Site Status

Site Reference ID/Investigator# 51008

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 47842

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 68462

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 51005

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 51009

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 51011

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 48210

Přerov, , Czechia

Site Status

Site Reference ID/Investigator# 45487

Rakovník, , Czechia

Site Status

Site Reference ID/Investigator# 51012

Slaný, , Czechia

Site Status

Site Reference ID/Investigator# 51002

Sokolov, , Czechia

Site Status

Site Reference ID/Investigator# 43448

Trutnov, , Czechia

Site Status

Site Reference ID/Investigator# 45485

Vyškov, , Czechia

Site Status

Site Reference ID/Investigator# 42992

Bacau, , Romania

Site Status

Site Reference ID/Investigator# 42879

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42880

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42881

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42882

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42883

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42963

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42970

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42877

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42878

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42973

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42975

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42976

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 42981

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 42982

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 42980

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 63623

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 43009

Constanța, , Romania

Site Status

Site Reference ID/Investigator# 43002

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 43003

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 43006

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 42991

Iași, , Romania

Site Status

Site Reference ID/Investigator# 42988

Iași, , Romania

Site Status

Site Reference ID/Investigator# 42989

Iași, , Romania

Site Status

Site Reference ID/Investigator# 42999

Oradea, , Romania

Site Status

Site Reference ID/Investigator# 43000

Oradea, , Romania

Site Status

Site Reference ID/Investigator# 42979

Ploieşti, , Romania

Site Status

Site Reference ID/Investigator# 42984

Târgu Mureş, , Romania

Site Status

Site Reference ID/Investigator# 42985

Târgu Mureş, , Romania

Site Status

Site Reference ID/Investigator# 42987

Târgu Mureş, , Romania

Site Status

Site Reference ID/Investigator# 42994

Timișoara, , Romania

Site Status

Site Reference ID/Investigator# 42995

Timișoara, , Romania

Site Status

Countries

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Bulgaria Czechia Romania

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P12-269

Identifier Type: -

Identifier Source: org_study_id

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