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A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

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ClinicalTrials.gov Identifier: NCT01506947
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Interventions: Drug: Paricalcitol
Drug: Darbepoetin alfa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 7 centers in Turkey.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paricalcitol

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.


Participant Flow:   Overall Study
    Paricalcitol
STARTED   65 
COMPLETED   49 
NOT COMPLETED   16 
Lost to Follow-up                7 
Adverse Event                5 
Death                1 
Did Not Meet Eligibility Criteria                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The per-protocol analysis set which included participants who completed the study according to the protocol. One patient was enrolled into the study under protocol version 1.0 and was not included in the per-protocol analysis set due to subsequent major changes to the protocol.

Reporting Groups
  Description
Paricalcitol

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.


Baseline Measures
   Paricalcitol 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (16.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26  54.2% 
Male      22  45.8% 


  Outcome Measures

1.  Primary:   Mean Erythropoietin Dose Per Visit   [ Time Frame: Baseline and Months 1, 2, 3, 4, 5 and 6 ]

2.  Secondary:   Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire   [ Time Frame: Baseline and Month 6 ]

3.  Secondary:   Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

4.  Secondary:   Mean Calcium Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

5.  Secondary:   Mean Phosphorus Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

6.  Secondary:   Mean Alkaline Phosphatase Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

7.  Secondary:   Vitamin B12 Levels   [ Time Frame: Baseline and month 6 ]

8.  Secondary:   Folic Acid Levels   [ Time Frame: Baseline and month 6 ]

9.  Secondary:   Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

10.  Secondary:   Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6   [ Time Frame: Baseline and Month 6 ]

11.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01506947     History of Changes
Other Study ID Numbers: W12-645
First Submitted: December 28, 2011
First Posted: January 10, 2012
Results First Submitted: April 6, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017