⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for 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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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

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

Study ID: NCT01149291

Interventions

Study Description

Brief Summary: 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.

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Site Reference ID/Investigator# 37822, Antalya, , Turkey

Site Reference ID/Investigator# 68286, Antalya, , Turkey

Site Reference ID/Investigator# 40677, Antalya, , Turkey

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, Istanbul, , Turkey

Site Reference ID/Investigator# 69973, İstanbul, , Turkey

Site Reference ID/Investigator# 63763, Izmir, , Turkey

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

Site Reference ID/Investigator# 68281, Mersin, , Turkey

Site Reference ID/Investigator# 68282, Mersin, , Turkey

Site Reference ID/Investigator# 69974, Mersin, , Turkey

Contact Details

Name: Mahmut Gucuk, MD

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: