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

NCT01224782 | Completed Results

• 1 other identifier: P12-269
• Study Type: observational
• Target: 994
• Locations: 3 countries
• Sites: 69

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.

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism

Keywords

Zemplar capsules; Chronic kidney disease (CKD) stage 3 or 4; Secondary hyperparathyroidism (SHPT); Postmarketing observational study (PMOS)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)

  From Baseline up to 12 Months

• Percentage of Participants With Hypercalcemia

  From Baseline up to 12 months

• Mean Weekly Dose of Zemplar (Paricalcitol)

  From Baseline up to 12 months

• 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)

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (69)

Site Reference ID/Investigator# 66544

Montana, 3400, Bulgaria

Location

Site Reference ID/Investigator# 47685

Pleven, 5800, Bulgaria

Location

Site Reference ID/Investigator# 66546

Plovdiv, 4001, Bulgaria

Location

Site Reference ID/Investigator# 47683

Sofia, 1257, Bulgaria

Location

Site Reference ID/Investigator# 66543

Sofia, 1407, Bulgaria

Location

Site Reference ID/Investigator# 47684

Sofia, 1431, Bulgaria

Location

Site Reference ID/Investigator# 66542

Sofia, 1431, Bulgaria

Location

Site Reference ID/Investigator# 66545

Sofia, 1709, Bulgaria

Location

Site Reference ID/Investigator# 47687

Varna, 9010, Bulgaria

Location

Site Reference ID/Investigator# 43449

Beroun, 266 01, Czechia

Location

Site Reference ID/Investigator# 46744

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 73353

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 47690

Brno, 61500, Czechia

Location

Site Reference ID/Investigator# 46742

České Budějovice, 370 01, Czechia

Location

Site Reference ID/Investigator# 49542

Frýdek-Místek, 738 01, Czechia

Location

Site Reference ID/Investigator# 67442

Jilemnice, 514 15, Czechia

Location

Site Reference ID/Investigator# 67443

Jilemnice, 514 15, Czechia

Location

Site Reference ID/Investigator# 51003

Karlovy Vary, 360 66, Czechia

Location

Site Reference ID/Investigator# 51004

Mariánské Lázně, 353 01, Czechia

Location

Site Reference ID/Investigator# 43522

Nový Jičín, 74101, Czechia

Location

Site Reference ID/Investigator# 43523

Nový Jičín, 74101, Czechia

Location

Site Reference ID/Investigator# 43524

Nový Jičín, 74101, Czechia

Location

Site Reference ID/Investigator# 45483

Olomouc, 779 00, Czechia

Location

Site Reference ID/Investigator# 43453

Ostrava, 700 30, Czechia

Location

Site Reference ID/Investigator# 46743

Pilsen, 323 18, Czechia

Location

Site Reference ID/Investigator# 51008

Prague, 10034, Czechia

Location

Site Reference ID/Investigator# 47842

Prague, 118 00, Czechia

Location

Site Reference ID/Investigator# 68462

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 51005

Prague, 15006, Czechia

Location

Site Reference ID/Investigator# 51009

Prague, Czechia

Location

Site Reference ID/Investigator# 51011

Prague, Czechia

Location

Site Reference ID/Investigator# 48210

Přerov, 750 02, Czechia

Location

Site Reference ID/Investigator# 45487

Rakovník, 269 29, Czechia

Location

Site Reference ID/Investigator# 51012

Slaný, Czechia

Location

Site Reference ID/Investigator# 51002

Sokolov, 356 01, Czechia

Location

Site Reference ID/Investigator# 43448

Trutnov, 541 21, Czechia

Location

Site Reference ID/Investigator# 45485

Vyškov, 682 01, Czechia

Location

Site Reference ID/Investigator# 42992

Bacau, Romania

Location

Site Reference ID/Investigator# 42879

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42880

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42881

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42882

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42883

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42963

Bucharest, 010731, Romania

Location

Site Reference ID/Investigator# 42970

Bucharest, 022328, Romania

Location

Site Reference ID/Investigator# 42877

Bucharest, Romania

Location

Site Reference ID/Investigator# 42878

Bucharest, Romania

Location

Site Reference ID/Investigator# 42973

Bucharest, Romania

Location

Site Reference ID/Investigator# 42975

Bucharest, Romania

Location

Site Reference ID/Investigator# 42976

Bucharest, Romania

Location

Site Reference ID/Investigator# 42981

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 42982

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 42980

Cluj-Napoca, 400139, Romania

Location

Site Reference ID/Investigator# 63623

Cluj-Napoca, 400139, Romania

Location

Site Reference ID/Investigator# 43009

Constanța, 900591, Romania

Location

Site Reference ID/Investigator# 43002

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 43003

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 43006

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 42991

Iași, 700503, Romania

Location

Site Reference ID/Investigator# 42988

Iași, Romania

Location

Site Reference ID/Investigator# 42989

Iași, Romania

Location

Site Reference ID/Investigator# 42999

Oradea, 410450, Romania

Location

Site Reference ID/Investigator# 43000

Oradea, 410450, Romania

Location

Site Reference ID/Investigator# 42979

Ploieşti, 100097, Romania

Location

Site Reference ID/Investigator# 42984

Târgu Mureş, Romania

Location

Site Reference ID/Investigator# 42985

Târgu Mureş, Romania

Location

Site Reference ID/Investigator# 42987

Târgu Mureş, Romania

Location

Site Reference ID/Investigator# 42994

Timișoara, Romania

Location

Site Reference ID/Investigator# 42995

Timișoara, Romania

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Corina Ionescu, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

BU (9); RO (32); CZ (28)