A Prospective Open-Label, Non-randomised, Single-arm, Pilot Clinical Study Evaluating the Effect of PTH Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
This study will be a prospective open label, non-randomised, single-arm, pilot clinical study evaluating the Effect of PTH Lowering on erythropoietin consumption in calcitriol resistant patients with stage 5 chronic kidney disease.
Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Open Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-resistant Patients|
- change in erythropoietin (EPO) consumption in patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]EPO dosage required to keep serum haemoglobin levels between 10 to 11,5 g/dl will be recorded.The recordings and blood tests to assess the haemoglobin levels will be conducted monthly.
- change in the quality of life scores of patients with chronic kidney disease (CKD) [ Time Frame: 6 months ] [ Designated as safety issue: No ]The quality of life of patients will be evaluated by using the SF-36 Questionnaire.
- the changes in commonly assessed biochemical parameters for bone and mineral metabolism (intact parathyroid hormone [iPTH], Calcium [Ca], Phosphorus [P], Vitamin B12, Folic acid ,Alkaline Phosphatase [ALP]) during treatment with paricalcitol. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Blood tests
- change in High-sensitivity C-Reactive Protein (hsCRP) and Fibroblast growth factor 23 (FGF-23) values [ Time Frame: 6 months ] [ Designated as safety issue: No ]Blood tests
- Safety: Adverse Events-The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Paricalcitol will be administered by intravenous route, and will be initiated in patients with a intact parathyroid hormone (iPTH) level >500 pg/mL, and the starting dose will be calculated according to the following formula; paricalcitol (µg) for each dialysis session= intact parathyroid hormone (iPTH) (pg/mL)/120.
Other Name: ABT-358 Zemplar
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506947
|Contact: Sevgi Serinoglu, BS||+90 216 firstname.lastname@example.org|
|Contact: Senem Gülcü Kurtiş, BS||+90 216 email@example.com|
|Site Reference ID/Investigator# 49203||Withdrawn|
|Instanbul, Turkey, 34899|
|Site Reference ID/Investigator# 49202||Recruiting|
|Istanbul, Turkey, 34093|
|Principal Investigator: Site Reference ID/Investigator# 49202|
|Site Reference ID/Investigator# 83893||Recruiting|
|Istanbul, Turkey, 34890|
|Principal Investigator: Site Reference ID/Investigator# 83893|
|Site Reference ID/Investigator# 83894||Recruiting|
|Istanbul, Turkey, 34098|
|Principal Investigator: Site Reference ID/Investigator# 83894|
|Site Reference ID/Investigator# 83895||Recruiting|
|Istanbul, Turkey, 34371|
|Principal Investigator: Site Reference ID/Investigator# 83895|
|Site Reference ID/Investigator# 83896||Recruiting|
|Istanbul, Turkey, 34730|
|Principal Investigator: Site Reference ID/Investigator# 83896|
|Study Director:||Mahmut Gücük, MD||AbbVie|