Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

NCT01081665 | Completed Results

• 1 other identifier: P06-120
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 19

Brief Summary

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

Conditions

Chronic Kidney Failure; Secondary Hyperparathyroidism

Keywords

Chronic Kidney Failure; Secondary Hyperparathyroidism; Paricalcitol IV treatment; Safety and efficacy assessment

Outcome Measures

Primary Outcomes (2)

• Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations

  The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.

  Baseline to Month 24 Visit

• Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized

  The mean (average) number of days hospitalized per participant for those hospitalized during the study.

  Baseline to Month 24 Visit

Secondary Outcomes (5)

• The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)

  Baseline to Month 24 Visit

• The Incidence of Clinically Significant Hypercalcemia

  Baseline to Month 24 Visit

• The Incidence of Clinically Significant Hyperphosphatemia

  Baseline to Month 24 Visit

• The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product

  Baseline to Month 24 Visit

• To Estimate the Incidence of (S)AEs/(S)ADRs

  Baseline to Month 24 Visit

Study Arms (1)

Chronic Kidney Disease

All eligible patients treated with IV Paricalcitol (Zemplar)

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

Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

You may qualify if:

• Subject is \>= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone \> 300 pg/mL.
• Subject is receiving chronic hemodialysis.
• Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
• Subject has provided their informed consent to participate.

You may not qualify if:

• Subject has a corrected serum calcium \> 10.5 mg/dL, serum phosphorus \>= 6.5 mg/dL or subjects with corrected Ca x P \>= 65 mg\^2/dl\^2.
• Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
• Subject has participated in clinical study within the last month.
• Zemplar is contraindicated according to the Summary of Product Characteristics.

Sponsors & Collaborators

• Abbott: lead

Study Sites (19)

Site Reference ID/Investigator# 32055

Athens, 11526, Greece

Location

Site Reference ID/Investigator# 32050

Athens, 11528, Greece

Location

Site Reference ID/Investigator# 32051

Athens, 11528, Greece

Location

Site Reference ID/Investigator# 32049

Athens, 17237, Greece

Location

Site Reference ID/Investigator# 5283

Athens, Greece

Location

Site Reference ID/Investigator# 32056

Chalcis, 34100, Greece

Location

Site Reference ID/Investigator# 32057

Chania, 73100, Greece

Location

Site Reference ID/Investigator# 32077

Cholargós, 15562, Greece

Location

Site Reference ID/Investigator# 32058

Drama, 66100, Greece

Location

Site Reference ID/Investigator# 32076

Katerini, 60100, Greece

Location

Site Reference ID/Investigator# 32059

Kavala, 65201, Greece

Location

Site Reference ID/Investigator# 32053

Komotini, 69100, Greece

Location

Site Reference ID/Investigator# 32060

Lamia, 35100, Greece

Location

Site Reference ID/Investigator# 32061

Lefkada, 31100, Greece

Location

Site Reference ID/Investigator# 32062

Livadia, 32100, Greece

Location

Site Reference ID/Investigator# 32048

Piraeus, Greece

Location

Site Reference ID/Investigator# 32054

Preveza, 48100, Greece

Location

Site Reference ID/Investigator# 32063

Ptolemaida, 50200, Greece

Location

Site Reference ID/Investigator# 32075

Volos, 38222, Greece

Location

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: Abbott

1-800-633-9110

Study Officials

• Konstantinos Xynos, MD

  Abbott Laboratories Hellas S.A.

  STUDY CHAIR

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 27, 2010
• First Posted: March 5, 2010
• Study Start: December 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 27, 2012
• Results First Posted: March 12, 2012

Record last verified: 2012-03

Locations

GR (19)