A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism

January 9, 2015 updated by: AbbVie (prior sponsor, Abbott)

A 18 Months, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving sVDRA's for Prevention and Treatment of Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.

Study Overview

Status

Completed

Conditions

Detailed Description

The scientific purpose of this study is to obtain data on the use of sVDRA(Selective Vitamin D Receptor Activator) in real-life clinical practice. This study will allow us to observe drug effectiveness in a distinct geography. Treatment effects, as well as maintenance of the results will be recorded for a 18 months period in order to obtain experience in the long term use of sVDRA(Selective Vitamin D Receptor Activator). Furthermore in the centers, additional blood parameter, hsCRP (high sensitivity C-reactive protein), will be examined as part of the clinical routine.

The primary aim of the study is:

  • To assess percentage change in iPTH (intact parathyroid hormone) level monthly among hemodialysis patients with sHPT (secondary hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy.

Secondary aims are:

  • To observe changes in commonly assessed biochemical parameters for bone and mineral metabolism (Ca (Calcium), P (Phosphorus), ALP (Alkaline phosphatase) and additionally hsCRP (high sensitivity C-reactive protein) as cardiovascular inflammatory marker.
  • To evaluate routinely checked parameters like albumin, hemoglobin and dialysis adequacy (KT/V).
  • To collect and evaluate data from all adverse events in order to establish the safety profile of sVDRA(Selective Vitamin D Receptor Activator) in daily clinical practice.
  • To collect mortality data 6 months after 12 months of observational period or 6 months after drop out.

Patients will be followed for 12 months within the post-marketing observational study and will be checked for mortality data 6 months after this follow up period. The enrollment period should not exceed 6 months.

All demographic information will be summarized by using descriptive statistics and graphs. Laboratory levels will be assessed by using mean, median, minimum, maximum, standard deviation and percentages on visit basis. The mean differences on laboratory levels between visits will also be summarized by graphics and assessed by using percentages.

Alkaline phosphatase and hsCRP (high sensitivity C-reactive protein) levels will also be summarized by using descriptive statistics and graphs per visit.

sVDRA (Selective Vitamin D Receptor Activator) dose changes per visits will be summarized by descriptive statistics and graphs.

Mortality will be analyzed with life tables. By taking into account the primary and secondary aims of the study, to be able to achieve the therapeutic success on iPTH (intact parathyroid hormone) level changes with sVDRA (Selective Vitamin D Receptor Activator) treatment and perform mortality assessment in following 6 months and collect data regarding safety and efficacy of sVDRAs (Selective Vitamin D Receptor Activators) in long term use, it has been determined to enroll totally 510 patients from 30 sites.

Study Type

Observational

Enrollment (Actual)

511

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07059
        • Site Reference ID/Investigator# 37822
      • Antalya, Turkey, 7130
        • Site Reference ID/Investigator# 68286
      • Antalya, Turkey
        • Site Reference ID/Investigator# 40677
      • Istanbul, Turkey, 34180
        • Site Reference ID/Investigator# 85153
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 40672
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 40674
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 40678
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 40686
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 61585
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 63764
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 63765
      • Istanbul, Turkey
        • Site Reference ID/Investigator# 63766
      • Izmir, Turkey, 7070
        • Site Reference ID/Investigator# 63763
      • Izmir, Turkey
        • Site Reference ID/Investigator# 48127
      • Karaman, Turkey
        • Site Reference ID/Investigator# 64444
      • Kayseri, Turkey
        • Site Reference ID/Investigator# 40684
      • Konya, Turkey
        • Site Reference ID/Investigator# 48132
      • Kutahya, Turkey, 43260
        • Site Reference ID/Investigator# 68283
      • Mersin, Turkey, 33000
        • Site Reference ID/Investigator# 68281
      • Mersin, Turkey, 33000
        • Site Reference ID/Investigator# 68282
      • Mersin, Turkey
        • Site Reference ID/Investigator# 69974
      • İstanbul, Turkey
        • Site Reference ID/Investigator# 69973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESRD (End Stage Renal Disease) patients undergoing hemodialysis who at the time of entry are receiving sVDRA's (Selective Vitamin D Receptor Activator) as it is prescribed in the normal clinical setting and according to the approved SmPC (Summary of Product Characteristics) for the prevention or treatment of secondary hyperparathyroidism.

Description

Inclusion Criteria:

  • Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 5 and receiving hemodialysis who is treated with sVDRA's (Selective Vitamin D Receptor Activator) injection
  • iPTH (intact parathyroid hormone) >300pg/ml, corrected serum Ca (Calcium) < 10.2 mg/dl, serum P (Phosphorus) < 6 mg/dl
  • Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients equal to or older than 18 years of age
  • Signed Informed consent by subject
  • Hypertensive and Diabetic subjects must be on an optimal and steady medication regimen for more than 30 days

Exclusion Criteria:

  • Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
  • Subject has participated in a clinical study within the last month
  • If sVDRA's (Selective Vitamin D Receptor Activator) are contraindicated according to the SmPC (Summary of Product Characteristics)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
End stage renal disease patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess percentage change in iPTH (intact Parathyroid Hormone) level monthly among hemodialysis patients with SHPT (Secondary Hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 0
Month 0
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 1
Month 1
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 2
Month 2
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 3
Month 3
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 4
Month 4
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 5
Month 5
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 6
Month 6
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 7
Month 7
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 8
Month 8
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 9
Month 9
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 10
Month 10
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 11
Month 11
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 12
Month 12
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: After early termination
After early termination
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 0
Month 0
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 1
Month 1
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 2
Month 2
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 3
Month 3
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 4
Month 4
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 5
Month 5
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 6
Month 6
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 7
Month 7
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 8
Month 8
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 9
Month 9
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 10
Month 10
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 11
Month 11
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 12
Month 12
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: After early termination
After early termination
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 0
Month 0
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 3
Month 3
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 6
Month 6
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 9
Month 9
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 12
Month 12
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: After early termination
After early termination
Serious Adverse events
Time Frame: 18 months
18 months
Mortality data
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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