A Prospective Open-Label, Non-randomised, Single-arm, Pilot Clinical Study Evaluating the Efficacy of Paricalcitol On Erythropoietin Consumption in Calcitriol-Resistant Patients

This study has suspended participant recruitment.
(Due to significant protocol changes with Amendment 2.)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01506947
First received: December 28, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This study will be a prospective open label, non-randomised, single-arm, pilot clinical study evaluating the efficacy of paricalcitol 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: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open Label Pilot Clinical Study Evaluating the Efficacy of Paricalcitol 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 11 to 12 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: 50
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

  Eligibility

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

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 < 75 mg2/dL2
  • Patients willing to sign "written informed consents" before participating in any the study related activity.

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.
  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

Locations
Turkey
Site Reference ID/Investigator# 49202
Istanbul, Turkey, 34093
Site Reference ID/Investigator# 83893
Istanbul, Turkey, 34890
Site Reference ID/Investigator# 83894
Istanbul, Turkey, 34098
Site Reference ID/Investigator# 83895
Istanbul, Turkey, 34371
Site Reference ID/Investigator# 83896
Istanbul, Turkey, 34730
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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: April 30, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by AbbVie:
Secondary hyperparathyroidism,
Hemodialysis
Chronic kidney disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Calcitriol
Ergocalciferols
Epoetin Alfa
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 29, 2014