Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis

NCT01084538 | Completed Results

• 1 other identifier: P10-231
• Study Type: observational
• Target: 181
• Locations: 2 countries
• Sites: 21

Brief Summary

This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.

Conditions

Parathyroid Hormone

Keywords

paricalcitol iv; vitamin D; secondary hyperparathyroidism; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline

  Baseline through 12 months

Secondary Outcomes (3)

• Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)

  Baseline through 12 months

• Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL

  Baseline through 12 months

• Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.

  Baseline through 12 months

Study Arms (1)

End stage chronic kidney disease

Secondary hyperparathyroidism defined as intact PTH \> 300 pg/mL

Drug: Zemplar iv (paricalcitol iv)

Interventions

Zemplar iv (paricalcitol iv) DRUG

Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.

Also known as: Zemplar iv

End stage chronic kidney disease

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

Haemodialysis patients

You may qualify if:

• Subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment iPTH \> 300 pg/mL, receiving chronic hemodialysis.
• Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.

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.
• Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients, or has participated in clinical study within the last month

Sponsors & Collaborators

• Abbott: lead

Study Sites (21)

Site Reference ID/Investigator# 27525

Dubrovnik, 20000, Croatia

Location

Site Reference ID/Investigator# 27531

Imotski, 21260, Croatia

Location

Site Reference ID/Investigator# 6175

Karlovac, 47000, Croatia

Location

Site Reference ID/Investigator# 27528

Pula, 52100, Croatia

Location

Site Reference ID/Investigator# 27533

Rijeka, 51000, Croatia

Location

Site Reference ID/Investigator# 27523

Sisak, 44000, Croatia

Location

Site Reference ID/Investigator# 27529

Slavonski Brod, 35000, Croatia

Location

Site Reference ID/Investigator# 27530

Split, 1000, Croatia

Location

Site Reference ID/Investigator# 27524

Šibenik, 22000, Croatia

Location

Site Reference ID/Investigator# 27534

Trogir, 21220, Croatia

Location

Site Reference ID/Investigator# 27522

Vinkovci, 32000, Croatia

Location

Site Reference ID/Investigator# 27527

Zadar, 23000, Croatia

Location

Site Reference ID/Investigator# 27526

Zagreb, 10000, Croatia

Location

Site Reference ID/Investigator# 27532

Zagreb, 10000, Croatia

Location

Site Reference ID/Investigator# 27536

Belgrade, 11000, Serbia

Location

Site Reference ID/Investigator# 27538

Belgrade, 11000, Serbia

Location

Site Reference ID/Investigator# 27539

Belgrade, 11000, Serbia

Location

Site Reference ID/Investigator# 6169

Belgrade, 11000, Serbia

Location

Site Reference ID/Investigator# 27540

Belgrade, 11080, Serbia

Location

Site Reference ID/Investigator# 27535

Bor, 19210, Serbia

Location

Site Reference ID/Investigator# 27537

Kragujevac, 34000, Serbia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Marta Gunjaca, MD

  Abbott

  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 22, 2010
• First Posted: March 10, 2010
• Study Start: September 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 21, 2011
• Results First Posted: September 12, 2011

Record last verified: 2011-09

Locations

SE (7); CR (14)