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: June 25, 2014
Last verified: June 2014
  Purpose

This study was designed to evaluate the effectiveness, safety; impact on quality of life related to health and depressive symptoms when paricalcitol is administered in Venezuelan patients on hemodialysis, and who are on risk to develop secondary hyperparathyroidism associated, with stage V chronic kidney disease.

Through this observational, multicenter, non interventional study it will be possible to obtain data that will help to improve the better understanding of the clinical conditions of these patients who are on risk to develop secondary hyperparathyroidism, due to chronic kidney disease stage V and that are receiving hemodialysis, as well as the safety profile of the product through the experience with local population. Additionally, it will be obtained quantifiable information of impact on the quality of life related to health and depressive symptoms of patients, from theirs perspective.


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:
  • Proportion of patients achieving at least a 30% reduction in the levels of PTH from baseline compared with values in the final study visit [ Time Frame: Six Months (24 weeks) from baseline to final visit ] [ Designated as safety issue: No ]
    Proportion of patients achieving at least a 30% reduction in the levels of PTH from baseline compared with values in the final study visit, after a period of six (6) months of paricalcitol administration


Secondary Outcome Measures:
  • Number of episodes of hypercalcemia, hyperphosphatemia and elevations of calcium-phosphate product (Ca x P) registered [ Time Frame: From baseline week 0 (first paricalcitol dose) to final study visit week 24 ] [ Designated as safety issue: Yes ]
    Number of episodes of hypercalcemia, hyperphosphatemia and elevations of calcium-phosphate product (Ca x P)

  • Number of subjects achieving a level <300 pg/mL of PTH. [ Time Frame: From baseline (week 0) to final study visit (week 24) ] [ Designated as safety issue: No ]
    Number, proportion of subjects achieving PTH values less than 300 pg/ml

  • Time require to achieve a reduction in PTH levels below <300 pg/mL, or a reduction of 30%, or both compared with the baseline. [ Time Frame: From baseline (week 0) to final study visit (week 24) ] [ Designated as safety issue: No ]
    Time require to achieve a reduction in PTH levels below <300 pg/mL

  • Changes in HRQoL EQ-5D questionnaire parameters, according the score from baseline to final visit. [ Time Frame: From baseline (week 0) to final study visit (week 24) ] [ Designated as safety issue: No ]
    Changes in HRQoL EQ-5D questionnaire

  • Changes in Beck's Depression Inventory [ Time Frame: From baseline (week 0) to final study visit (week 24) ] [ Designated as safety issue: No ]
    Changes and prevalence of depressive symptoms measured by Beck's Depression Inventory


Enrollment: 100
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
Cohort 1

  Eligibility

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

Subjects with diagnosis of Chronic Kidney Disease Stage V undergoing Hemodialysis

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 (IUD, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment

Exclusion Criteria:

  • Subjects with severe hyperparathyroidism (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: Juan F Semeco, 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
Last Updated: June 25, 2014
Health Authority: Venezuela: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014