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 is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by AbbVie
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
First received: December 28, 2011
Last updated: February 20, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Drug: Paricalcitol
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 65
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)
Arms Assigned Interventions
Paricalcitol Drug: Paricalcitol
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A subject will only be included if all the following entry criteria are met:

  • Patients >=18 years of age
  • Stage 5 CKD patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT) receiving hemodialysis
  • Patients with anemia receiving EPO therapy with iron repletion; Transferrin saturation (TSAT) > 20% and Ferritin levels > 200 ng/mL and requiring treatment with erythropoietin (EPO)
  • Patients with Vitamin B levels > LLN and Folic acid levels > LLN
  • SATPatients with Vitamin B levels > LLN and Folic acid levels > LLN
  • Patients treated only with intravenous calcitriol for at least 6 months
  • Patients with serum iPTH level > 500 pg/mL
  • Patients with Ca . PO4 product < 65 mg2/dL2
  • Patients willing to sign "written informed consents" before participating in any the study related activity.
  • Patients with Ca levels <6.5 mg/dL and P levels <11.2 mg/dL

Exclusion Criteria:

A subject will be excluded from the study if he/she meets any of the following criteria:

  • Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
  • Patients who have participated in a clinical study within the last month.
  • Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
  • Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the SmPC.
  • Pregnancy, Female patients pregnant, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
  • Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
  • Patients with microcytic (MCV < 80 fL) and macrocytic (MCV> 100 fL) anemia at screening baseline that may be caused by diseases such as Micros- Fe Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zn poisoning, Sideroblastic Anemia, Macros-ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.
  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: NCT01506947

Contact: Sevgi Serinoglu, BS +90 216 6360367 sevgi.serinoglu@abbvie.com
Contact: Senem Gülcü Kurtiş, BS +90 216 6360366 senem.kurtis@abbvie.com

Site Reference ID/Investigator# 49203 Withdrawn
Instanbul, Turkey, 34899
Site Reference ID/Investigator# 130949 Recruiting
Istanbul, Turkey, 34147
Principal Investigator: Site Reference ID/Investigator# 130949         
Site Reference ID/Investigator# 131209 Recruiting
Istanbul, Turkey, 34200
Principal Investigator: Site Reference ID/Investigator# 131209         
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         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Mahmut Gücük, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01506947     History of Changes
Other Study ID Numbers: W12-645
Study First Received: December 28, 2011
Last Updated: February 20, 2015
Health Authority: Turkey: Ministry of Health

Keywords provided by AbbVie:
Secondary hyperparathyroidism,
Chronic kidney disease

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Endocrine System Diseases
Kidney Diseases
Parathyroid Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on March 30, 2015