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Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

This study has been terminated.
(Changes in country regulation)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01758289
First received: December 27, 2012
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

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
Chronic Kidney Disease Stage V
Hemodialysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 [ Time Frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) ] [ Designated as safety issue: Yes ]

    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).


  • Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL [ Time Frame: Baseline to Week 12, Week 12 to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks [ Time Frame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) ] [ Designated as safety issue: No ]
    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).

  • 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 [ Time Frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) ] [ Designated as safety issue: No ]
    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.

  • European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 [ Time Frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) ] [ Designated as safety issue: No ]
    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).

  • Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit [ Time Frame: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit) ] [ Designated as safety issue: No ]
    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.


Enrollment: 105
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study was conducted in 8 hemodialysis units distributed in Venezuela.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758289

Locations
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, Venezuela
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Jeanine Obage, MD Abbott
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01758289     History of Changes
Other Study ID Numbers: P13-785
Study First Received: December 27, 2012
Results First Received: November 7, 2014
Last Updated: November 7, 2014
Health Authority: Venezuela : Ministerio del Poder Popular para la Salud

Keywords provided by AbbVie:
Venezuelan Patients
Depressive Symptoms
Health Related Quality of Life

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014