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

This study has suspended participant recruitment.

(Enrollment on Hold)

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01506947

First received: December 28, 2011

Last updated: March 25, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2011

Last Updated Date

March 25, 2013

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01506947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.
change in the serum calcium (Ca) , phosphorus (P) , Alkaline Phosphatase (ALP) and Intact parathyroid hormone (iPTH) levels of the patients from baseline [ 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: baseline, month 1, month 3, up to month 6 ] [ 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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Open Label Pilot Clinical Study Evaluating the Efficacy of Paricalcitol on Erythropoietin Consumption in Calcitriol-resistant Patients

Brief Summary

This study will be a prospective open label pilot clinical study evaluating the efficacy of paricalcitol on erythropoietin consumption in calcitriol resistant patients with stage 5 chronic kidney disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases

Intervention ^ICMJE

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

Study Arm (s)

Paricalcitol

Intervention: Drug: Paricalcitol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT01506947

Other Study ID Numbers ^ICMJE

W12-645

Has Data Monitoring Committee

Responsible Party

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Sponsor ^ICMJE

AbbVie (prior sponsor, Abbott)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Mahmut Gücük, MD

AbbVie

Information Provided By

AbbVie

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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