Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01758289
• Collaborator: (none)
• Enrollment: 105
• Locations: 8
• Duration (Months): 10
• Patients Per Site: 13.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Stage V; Hemodialysis

Study Design

• Study Type: Observational
• Actual Enrollment: 105 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Paricalcitol IV Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria.

Outcome Measures

Primary Outcome Measures

1. 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)]

Secondary Outcome Measures

1. Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 [Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)]

   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).

2. Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL [Baseline to Week 12, Week 12 to Week 24]

   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).

3. Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks [Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)]

   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).

4. 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 [Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)]

   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.

5. European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 [Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)]

   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).

6. Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit [Baseline Week 1 (Study Visit 1), Week 24 (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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 96757	Acarigua		Venezuela
2	Site Reference ID/Investigator# 96766	Barquisimeto		Venezuela
3	Site Reference ID/Investigator# 96768	Caracas		Venezuela
4	Site Reference ID/Investigator# 96760	Maracaibo		Venezuela
5	Site Reference ID/Investigator# 96761	Maracaibo		Venezuela
6	Site Reference ID/Investigator# 96770	Miranda		Venezuela
7	Site Reference ID/Investigator# 96763	Monagas		Venezuela
8	Site Reference ID/Investigator# 96765	Naguanagua		Venezuela

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Chair: Jeanine Obage, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01758289
• Other Study ID Numbers: P13-785
• First Posted: Jan 1, 2013
• Last Update Posted: Nov 17, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by AbbVie (prior sponsor, Abbott): Venezuelan Patients; Depressive Symptoms; Health Related Quality of Life
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

Participant Flow

Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Period Title: Overall Study
STARTED	105
COMPLETED	52
NOT COMPLETED	53

Baseline Characteristics

Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Overall Participants	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.00 (13.90)
Sex/Gender, Customized (participants) [Number]
Female	37 35.2%
Male	67 63.8%
Not Reported	1 1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
Time Frame	Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

Participants with valid PTH values at Baseline and Final Study Visit.

Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	50
Number [percentage of participants]	62 59%

2. Secondary Outcome

Title	Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
Description	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).
Time Frame	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

Participants with valid assessments at given time point.

Arm/Group Title	Paricalcitol IV: Baseline	Paricalcitol IV: Week 12	Paricalcitol IV: Week 24
Arm/Group Description	Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	105	70	50
Hypercalcemia	1.90 1.8%	1.42 NaN	14.00 NaN
Hyperphosphatemia	28.57 27.2%	42.85 NaN	38.00 NaN
Elevations of (Ca x P)	15.23 14.5%	32.85 NaN	20.00 NaN

3. Secondary Outcome

Title	Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL
Description	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).
Time Frame	Baseline to Week 12, Week 12 to Week 24

Outcome Measure Data

Analysis Population Description

All participants; n=participants with valid PTH values at given time point.

Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	105
Baseline to Week 12; n=70	14 13.3%
Week 12 to Week 24; n=50	14 13.3%

4. Secondary Outcome

Title	Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks
Description	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).
Time Frame	Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

All participants; n=number of participants with valid PTH values at given time point.

Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	105
Baseline to Week 12 (12 weeks); n=70	14 13.3%
Week 12 to Week 24 (12 weeks); n=50	13 12.4%
Baseline to Week 24 (24 weeks); n=50	16 15.2%

5. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

Participants with valid assessments at given time point.

Arm/Group Title	Paricalcitol IV: Baseline	Paricalcitol IV: Week 12	Paricalcitol IV: Week 24
Arm/Group Description	Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	104	70	50
Mobility: No Problems	64 61%	36 NaN	27 NaN
Mobility: Slight Problems	13 12.4%	15 NaN	13 NaN
Mobility: Moderate Problems	13 12.4%	6 NaN	8 NaN
Mobility: Severe Problems	5 4.8%	3 NaN	2 NaN
Mobility: Unable to Walk About	1 1%	0 NaN	0 NaN
Mobility: Unknown	8 7.6%	10 NaN	0 NaN
Self-Care: No Problems	80 76.2%	50 NaN	40 NaN
Self-Care: Slight Problems	8 7.6%	3 NaN	7 NaN
Self-Care: Moderate Problems	5 4.8%	3 NaN	3 NaN
Self-Care: Severe Problems	0 0%	3 NaN	0 NaN
Self-Care: Unable to Wash or Dress Self	3 2.9%	1 NaN	0 NaN
Self-Care: Unknown	8 7.6%	10 NaN	0 NaN
Usual Activities: No Problems	53 50.5%	37 NaN	28 NaN
Usual Activities: Slight Problems	26 24.8%	13 NaN	15 NaN
Usual Activities: Moderate Problems	9 8.6%	6 NaN	5 NaN
Usual Activities: Severe Problems	5 4.8%	2 NaN	1 NaN
Usual Activities: Unable to Do Usual Activities	3 2.9%	2 NaN	1 NaN
Usual Activities: Unknown	8 7.6%	10 NaN	0 NaN
Pain/Discomfort: None	39 37.1%	30 NaN	21 NaN
Pain/Discomfort: Slight	41 39%	20 NaN	18 NaN
Pain/Discomfort: Moderate	13 12.4%	9 NaN	10 NaN
Pain/Discomfort: Severe	2 1.9%	1 NaN	1 NaN
Pain/Discomfort: Extreme	2 1.9%	0 NaN	0 NaN
Pain/Discomfort: Unknown	7 6.7%	10 NaN	0 NaN
Anxiety/Depression: None	66 62.9%	46 NaN	39 NaN
Anxiety/Depression: Slight	24 22.9%	11 NaN	9 NaN
Anxiety/Depression: Moderate	4 3.8%	2 NaN	2 NaN
Anxiety/Depression: Severe	3 2.9%	0 NaN	0 NaN
Anxiety/Depression: Extreme	0 0%	0 NaN	0 NaN
Anxiety/Depression: Unknown	7 6.7%	11 NaN	0 NaN

6. Secondary Outcome

Title	European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24
Description	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).
Time Frame	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

Participants with valid assessments at given time point.

Arm/Group Title	Paricalcitol IV: Baseline	Paricalcitol IV: Week 12	Paricalcitol IV: Week 24
Arm/Group Description	Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	94	59	48
Mean (Standard Deviation) [units on a scale]	77.98 (16.21)	84.31 (14.52)	80.33 (18.28)

7. Secondary Outcome

Title	Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
Description	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.
Time Frame	Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)

Outcome Measure Data

Analysis Population Description

Participants with a complete, valid assessment at given time point.

Arm/Group Title	Paricalcitol IV: Baseline	Paricalcitol IV: Week 24
Arm/Group Description	Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.	Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
Measure Participants	88	45
Mean (Standard Deviation) [units on a scale]	10.39 (7.04)	7.96 (5.75)

Adverse Events

Time Frame	From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
Arm/Group Title	Paricalcitol IV
Arm/Group Description	Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
All Cause Mortality
	Paricalcitol IV
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paricalcitol IV
	Affected / at Risk (%)	# Events
Total	9/105 (8.6%)
Cardiac disorders
Cardio-respiratory arrest	1/105 (1%)
Heart failure	1/105 (1%)
Myocardial infarction	1/105 (1%)
Infections and infestations
Sepsis	2/105 (1.9%)
Musculoskeletal and connective tissue disorders
Spinal cord compression	1/105 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid adenoma	1/105 (1%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/105 (1%)
Social circumstances
Drowning	1/105 (1%)
Other (Not Including Serious) Adverse Events
	Paricalcitol IV
	Affected / at Risk (%)	# Events
Total	21/105 (20%)
Cardiac disorders
Chest pain	1/105 (1%)
Gastrointestinal disorders
Gastritis	6/105 (5.7%)
General disorders
Pain	1/105 (1%)
Infections and infestations
Catheter related infection	2/105 (1.9%)
Pharyngitis	1/105 (1%)
Upper respiratory infection	1/105 (1%)
Musculoskeletal and connective tissue disorders
Pain in extremities	1/105 (1%)
Neck pain	1/105 (1%)
Nervous system disorders
Insomnia	4/105 (3.8%)
Neuropathic pain	2/105 (1.9%)
Vascular disorders
Hypotension	1/105 (1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.