Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

Hemodialysis Clinical Trial

Official title:

A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health Related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol Administered to Venezuelan Patients With Chronic Kidney Disease (Stage V) Who Are on Hemodialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01758289
• Other study ID #: P13-785
• Status: Terminated
• Phase: N/A
• First received: December 27, 2012
• Last updated: November 7, 2014
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela : Ministerio del Poder Popular para la Salud
• Study type: Observational

Clinical Trial Summary

This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female = 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline

• Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol

• Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela

• Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study

• Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment

Exclusion Criteria:

• Subjects with severe hyperparathyroidism (parathyroid hormone [PTH] > 3000 pg/mL)

• Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) = 70

• Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)

• Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product

• Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum

• Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage V
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Venezuela	Site Reference ID/Investigator# 96757	Acarigua
Venezuela	Site Reference ID/Investigator# 96766	Barquisimeto
Venezuela	Site Reference ID/Investigator# 96768	Caracas
Venezuela	Site Reference ID/Investigator# 96760	Maracaibo
Venezuela	Site Reference ID/Investigator# 96761	Maracaibo
Venezuela	Site Reference ID/Investigator# 96770	Miranda
Venezuela	Site Reference ID/Investigator# 96763	Monagas
Venezuela	Site Reference ID/Investigator# 96765	Naguanagua

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit		Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)	No
Secondary	Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24	Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.; Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.; Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL).	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	Yes
Secondary	Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL	Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).	Baseline to Week 12, Week 12 to Week 24	No
Secondary	Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks	Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).	Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)	No
Secondary	European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24	The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	No
Secondary	European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24	The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	No
Secondary	Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit	BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.	Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)	No