Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

This study has been terminated.

(Low enrollment rate)

Sponsor:

Collaborator:

Statistika Consultoria Ltda

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT00664430

First received: April 21, 2008

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Results First Received: June 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Secondary Hyperparathyroidism Dialysis
Interventions:	Drug: Calcitriol Drug: Paricalcitol

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After Screening, participants entered an 8-week controlled calcitriol period. Participants whose parathyroid hormone (PTH) levels decreased after 8 weeks (i.e., participants who were not resistant to calcitriol) were discontinued from the study.

Reporting Groups

	Description
Calcitriol Challenge Followed by Paricalcitol	To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.

Participant Flow: Overall Study

	Calcitriol Challenge Followed by Paricalcitol
STARTED	13
COMPLETED	0 ^[1]
NOT COMPLETED	13

[1]	Study terminated early due to low enrollment rate.

Baseline Characteristics

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Reporting Groups

	Description
Calcitriol Challenge Followed by Paricalcitol	To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.

Baseline Measures

	Calcitriol Challenge Followed by Paricalcitol
Number of Participants [units: participants]	13
Age [units: participants]
<=18 years	0
Between 18 and 65 years	12
>=65 years	1
Gender [units: participants]
Female	6
Male	7
Region of Enrollment [units: participants]
Brazil	13

Outcome Measures

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1. Primary:

Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values [ Time Frame: Up to Week 24 ]

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2. Secondary:

Changes in Bone Remodeling Markers Over Time [ Time Frame: Every 3 months ]

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3. Secondary:

Number of Participants With Adverse Events [ Time Frame: Up to 1 year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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
Early termination leading to no efficacy evaluation. All adverse events occurred during calcitriol challenge phase.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00664430 History of Changes
Other Study ID Numbers:	W10-131
Study First Received:	April 21, 2008
Results First Received:	June 3, 2010
Last Updated:	January 18, 2012
Health Authority:	Brazil: Ethics Committee Brazil: National Health Surveillance Agency

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