Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience

NCT01083186 | Completed Results

• 1 other identifier: P11-978
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.

Conditions

Chronic Kidney Failure; Secondary Hyperparathyroidism

Keywords

Secondary Hyperparathyroidism; Chronic Kidney Failure

Outcome Measures

Primary Outcomes (2)

• Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population

  iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.

  Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

• Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants

  iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.

  Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Secondary Outcomes (22)

• Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels

  Measured from start of study, up to a maximum of 12 months

• Mean Duration of Effect Sustainability (Months)

  Measured from start of study, up to a maximum of 12 months

• Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range

  Enrollment Visit, Month 3, Month 6, Month 9, Month 12

• Number of Participants With Serum Calcium Level Abnormalities

  Baseline, Enrollment Visit, Month 6, Month 12

• Number of Participants With Serum Phosphorus Level Abnormalities

  Baseline, Enrollment Visit, Month 6, Month 12

Study Arms (1)

Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism

Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 24 hospital-based specialty, nephrology clinics in Greece

You may qualify if:

• Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment
• Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age
• Signed informed consent by subject
• Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days

You may not qualify if:

• Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II)
• Parathormone value of \> 1000 pg/mL (sign of tertiary hyperparathyroidism)

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (24)

Site Reference ID/Investigator# 47002

Arta, 47100, Greece

Location

Site Reference ID/Investigator# 43772

Athens, 115 21, Greece

Location

Site Reference ID/Investigator# 27492

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 43769

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 38257

Athens, 11526, Greece

Location

Site Reference ID/Investigator# 47003

Athens, 11526, Greece

Location

Site Reference ID/Investigator# 27497

Athens, 11527, Greece

Location

Site Reference ID/Investigator# 47004

Athens, 11527, Greece

Location

Site Reference ID/Investigator# 27489

Athens, 11528, Greece

Location

Site Reference ID/Investigator# 27495

Athens, 16673, Greece

Location

Site Reference ID/Investigator# 43773

Athens, 17237, Greece

Location

Site Reference ID/Investigator# 27498

Haidari, Athens, 12462, Greece

Location

Site Reference ID/Investigator# 38259

Ioannina, 45500, Greece

Location

Site Reference ID/Investigator# 22121

Larissa, 411 10, Greece

Location

Site Reference ID/Investigator# 43771

Larissa, 41223, Greece

Location

Site Reference ID/Investigator# 43767

Maroussi Athens, 15123, Greece

Location

Site Reference ID/Investigator# 27496

Nikaia, 18454, Greece

Location

Site Reference ID/Investigator# 43768

North Ionia, Athens, 142 33, Greece

Location

Site Reference ID/Investigator# 27491

Piraeus, 18536, Greece

Location

Site Reference ID/Investigator# 27494

Thessaloniki, 546 36, Greece

Location

Site Reference ID/Investigator# 27493

Thessaloniki, 54636, Greece

Location

Site Reference ID/Investigator# 38255

Thessaloniki, 56403, Greece

Location

Site Reference ID/Investigator# 43770

Thessaloniki, 570 01, Greece

Location

Site Reference ID/Investigator# 39839

Thessaloniki, Greece

Location

Related Links

• Related info

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

• Christos Argyropoulos, MD

  AbbVie Pharmaceuticals S.A.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2010
• First Posted: March 9, 2010
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 12, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-03

Locations

GR (24)