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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01149291
First received: June 22, 2010
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition
Secondary Hyperparathyroidism
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

Secondary Outcome Measures:
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 5 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 10 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 11 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Calcium, Phosphorus, ALP (Alkaline Phosphatase) [ Time Frame: After early termination ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 5 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 10 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 11 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Albumin, hemoglobin and dialysis adequacy (KT/V) [ Time Frame: After early termination ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • hsCRP (High Sensitivity C-Reactive Protein) [ Time Frame: After early termination ] [ Designated as safety issue: No ]
  • Serious Adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Mortality data [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 510
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
End stage renal disease patients

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.

  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

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.

Criteria

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)
  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: NCT01149291

Locations
Turkey
Site Reference ID/Investigator# 37822
Antalya, Turkey, 07059
Site Reference ID/Investigator# 40677
Antalya, Turkey
Site Reference ID/Investigator# 68286
Antalya, Turkey, 7130
Site Reference ID/Investigator# 63764
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# 40672
Istanbul, Turkey
Site Reference ID/Investigator# 63765
Istanbul, Turkey
Site Reference ID/Investigator# 63766
Istanbul, Turkey
Site Reference ID/Investigator# 85153
Istanbul, Turkey, 34180
Site Reference ID/Investigator# 69973
İstanbul, Turkey
Site Reference ID/Investigator# 63763
Izmir, Turkey, 7070
Site Reference ID/Investigator# 48127
Izmir, Turkey
Site Reference ID/Investigator# 64444
Karaman, Turkey
Site Reference ID/Investigator# 40684
Kayseri, Turkey
Site Reference ID/Investigator# 48132
Konya, Turkey
Site Reference ID/Investigator# 68283
Kutahya, Turkey, 43260
Site Reference ID/Investigator# 69974
Mersin, Turkey
Site Reference ID/Investigator# 68281
Mersin, Turkey, 33000
Site Reference ID/Investigator# 68282
Mersin, Turkey, 33000
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mahmut Gucuk, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01149291     History of Changes
Other Study ID Numbers: P12-314
Study First Received: June 22, 2010
Last Updated: July 10, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by AbbVie:
high sensitivity C-reactive protein (hsCRP)
cardiorenal
end stage renal disease (ESRD)
Secondary hyperparathyroidism (SHPT)
dialysis
paricalcitol
osteodystrophy
selective Vitamin D receptor activators (sVDRA)
chronic kidney disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014