Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

NCT01073462 | Completed Results

• 1 other identifier: P10-680
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease Stage V; Cardiac Morbidity

Keywords

Secondary Hyperparathyroidism (sHPT); Paricalcitol; Chronic kidney disease stage 5 (CKD stage 5)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range

  Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).

  Baseline and Months 3, 6, 12, 18, and 24

Secondary Outcomes (7)

• Percentage of Participants With Hypercalcemia

  Baseline and Months 3, 6, 12, 18, and 24

• Percentage of Participants With Hyperphosphatemia

  Baseline and Months 3, 6, 12, 18, and 24

• Percentage of Participants With at Least a 30%-Reduction in iPTH Levels

  Baseline and Months 3, 6, 12, 18, and 24

• Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements

  Baseline to Month 24

• Percentage of Participants With at Least One Concomitant Medication

  24 months

Study Arms (1)

Paricalcitol IV

Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.

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

Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.

You may qualify if:

• Patients aged at least 18 years
• Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH \> 150 pg/mL,
• Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
• cardiac disorder as cardiac arrhythmias
• cardiac disorder signs and symptoms
• cardiac neoplasm
• cardiac valve disorder
• heart failures
• myocardial disorder
• pericardial disorder
• Serum phosphate level \< 6.5 mg/dL and serum calcium level \< 10.5 mg/dL

You may not qualify if:

• Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics
• Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Assign Data Management and Biostatistics GmbH: collaborator

Study Sites (12)

Site Reference ID/Investigator# 27447

Graz, 8010, Austria

Location

Site Reference ID/Investigator# 49182

Graz, 8020, Austria

Location

Site Reference ID/Investigator# 27483

Graz, 80360, Austria

Location

Site Reference ID/Investigator# 52742

Graz, 8052, Austria

Location

Site Reference ID/Investigator# 27487

Innsbruck, 6020, Austria

Location

Site Reference ID/Investigator# 36983

Linz, 4010, Austria

Location

Site Reference ID/Investigator# 27484

Linz, 4020, Austria

Location

Site Reference ID/Investigator# 27485

Rottenmann, 8786, Austria

Location

Site Reference ID/Investigator# 27446

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 53469

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 27482

Vienna, 1130, Austria

Location

Site Reference ID/Investigator# 10981

Vienna, 1220, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; 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

Results Point of Contact

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

800-633-9110

Study Officials

• Astrid Dworan-Timler

  AbbVie Austria

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 20, 2010
• First Posted: February 23, 2010
• Study Start: December 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 10, 2014
• Results First Posted: July 10, 2014

Record last verified: 2014-06

Locations

AU (12)