Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01081665

First received: February 27, 2010

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Results First Received: February 7, 2012

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Conditions:	Chronic Kidney Failure Secondary Hyperparathyroidism

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
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Reporting Groups

	Description
Chronic Kidney Disease	All eligible patients treated with IV Paricalcitol (Zemplar)

Participant Flow: Overall Study

	Chronic Kidney Disease
STARTED	237
Full Analysis Set	237
Evaluable Population	212 ^[1]
COMPLETED	142
NOT COMPLETED	95
Death	41
Lost to Follow-up	18
Withdrawal by Subject	17
Change of dialysis unit	10
Regulation of iPTH	5
Change in renal replacement therapy	2
Adverse Event	1
Lack of Efficacy	1

[1]	Participants with baseline and at least 2 post-baseline parathormone measurements at 24 months.

Baseline Characteristics

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Reporting Groups

	Description
Chronic Kidney Disease	All eligible patients treated with IV Paricalcitol (Zemplar)

Baseline Measures

	Chronic Kidney Disease
Number of Participants [units: participants]	237
Age [units: years] Mean ± Standard Deviation	62.6 ± 13.7
Gender [units: participants]
Female	110
Male	127
Region of Enrollment [units: participants]
Greece	237
Age at chronic kidney disease diagnosis ^[1] [units: years] Mean ± Standard Deviation	53.6 ± 14.7
Time since chronic kidney disease diagnosis ^[2] [units: years] Mean ± Standard Deviation	8.8 ± 6.8
Time since starting haemodialysis ^[3] [units: years] Mean ± Standard Deviation	3.6 ± 4.4
Time since diagnosis of secondary hyperparathyroidism ^[4] [units: years] Mean ± Standard Deviation	2.0 ± 3.1

[1]	The age of participants when they were diagnosed with chronic kidney disease. Based on data reported by 222 participants.
[2]	The amount of time elapsed from the time the participant was diagnosed with chronic kidney disease to study entry. Based on data reported by 222 participants.
[3]	At study entry, the amount of time that had elapsed from participants first starting haemodialysis, a procedure that filters the blood to remove harmful wastes.
[4]	At study entry, the amount of time that had elapsed since participants were first diagnosed with hyperparathyroidism, a condition where the parathyroid glands make too much parathyroid hormone, causing an imbalance of calcium and phosphorous in the body. Based on data reported by 228 participants.

Outcome Measures

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1. Primary:

Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations [ Time Frame: Baseline to Month 24 Visit ]

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2. Primary:

Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized [ Time Frame: Baseline to Month 24 Visit ]

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3. Secondary:

The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) [ Time Frame: Baseline to Month 24 Visit ]

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4. Secondary:

The Incidence of Clinically Significant Hypercalcemia [ Time Frame: Baseline to Month 24 Visit ]

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5. Secondary:

The Incidence of Clinically Significant Hyperphosphatemia [ Time Frame: Baseline to Month 24 Visit ]

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6. Secondary:

The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product [ Time Frame: Baseline to Month 24 Visit ]

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7. Secondary:

To Estimate the Incidence of (S)AEs/(S)ADRs [ Time Frame: Baseline to Month 24 Visit ]

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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
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Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01081665 History of Changes
Other Study ID Numbers:	P06-120
Study First Received:	February 27, 2010
Results First Received:	February 7, 2012
Last Updated:	March 26, 2012
Health Authority:	Greece: National Organization of Medicines

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