The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors - Study Results

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors (VITAL)

This study has been completed.

Study NCT00421733 Information provided by Abbott

First Received on January 10, 2007. Last Updated on January 18, 2012 History of Changes

Results First Received: June 9, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Diabetic Nephropathy Chronic Kidney Disease
Interventions:	Drug: Zemplar (paricalcitol ) capsules Drug: Zemplar (paricalcitol) capsules Drug: Placebo

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
Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
Placebo	Two placebo capsules per dose

Participant Flow: Overall Study

	Paricalcitol 1 Mcg	Paricalcitol 2 Mcg	Placebo
STARTED	93	95	93
COMPLETED	78	69	73
NOT COMPLETED	15	26	20
Adverse Event	4	9	2
Lost to Follow-up	1	2	4
Withdrawal by Subject	1	2	7
Death	0	3	0
Required dialysis	1	0	0
Administrative	2	0	0
Did not satisfy entry criteria	1	3	2
Sponsor request	1	0	3
Protocol deviation	4	7	2

Baseline Characteristics

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Reporting Groups

	Description
Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
Placebo	Two placebo capsules per dose

Baseline Measures

	Paricalcitol 1 Mcg	Paricalcitol 2 Mcg	Placebo	Total
Number of Participants [units: participants]	93	95	93	281
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	45	47	44	136
>=65 years	48	48	49	145
Age [units: years] Mean ± Standard Deviation	64.0 ± 10.15	64.7 ± 9.92	64.5 ± 11.23	64.4 ± 10.41
Gender [units: participants]
Female	27	26	33	86
Male	66	69	60	195
Region of Enrollment [units: participants]
Portugal	2	2	0	4
United States	57	60	64	181
Taiwan	10	14	10	34
Greece	1	3	1	5
Poland	4	4	4	12
Spain	11	3	9	23
Netherlands	0	0	1	1
Germany	4	8	1	13
Italy	4	1	3	8

Outcome Measures

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1. Primary:

Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg). [ Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment ]

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2. Secondary:

Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels. [ Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment ]

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3. Secondary:

Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection. [ Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment ]

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4. Secondary:

Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels. [ Time Frame: Baseline (screening period) through 24 weeks of treatment ]

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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: 800-633-9110

No publications provided by Abbott

Publications automatically indexed to this study:

de Zeeuw D, Agarwal R, Amdahl M, Audhya P, Coyne D, Garimella T, Parving HH, Pritchett Y, Remuzzi G, Ritz E, Andress D. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet. 2010 Nov 6;376(9752):1543-51.

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00421733 History of Changes
Other Study ID Numbers:	M05-741, 2006-001363-31
Study First Received:	January 10, 2007
Results First Received:	June 9, 2010
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration