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

January 18, 2012 updated by: Abbott

VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With Renin-angiotensin System Inhibitors

The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40210
        • Site Reference ID/Investigator# 6316
      • Hannover, Germany, 30625
        • Site Reference ID/Investigator# 5167
      • Ludwigshafen, Germany, 67059
        • Site Reference ID/Investigator# 6302
  • Greece
      • Athens, Greece, 18454
        • Site Reference ID/Investigator# 6314
      • Ioannina, Greece, 45500
        • Site Reference ID/Investigator# 6306
      • Thessaloniki, Greece, 54636
        • Site Reference ID/Investigator# 5631
      • Thessaloniki, Greece, 54642
        • Site Reference ID/Investigator# 6310
  • Italy
      • Bergamo, Italy, 24128
        • Site Reference ID/Investigator# 6312
      • Brescia, Italy, 25123
        • Site Reference ID/Investigator# 6303
      • Milan, Italy, 20142
        • Site Reference ID/Investigator# 6309
      • Modena, Italy, 41100
        • Site Reference ID/Investigator# 6210
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Site Reference ID/Investigator# 6207
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Site Reference ID/Investigator# 6304
      • Katowice, Poland, 40027
        • Site Reference ID/Investigator# 5622
      • Szczecin, Poland, 70-111
        • Site Reference ID/Investigator# 5203
      • Warsaw, Poland, 00909
        • Site Reference ID/Investigator# 6315
  • Portugal
      • Lisbon, Portugal, 1069-166
        • Site Reference ID/Investigator# 6327
      • Porto, Portugal, 4202-451
        • Site Reference ID/Investigator# 6326
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Site Reference ID/Investigator# 6916
      • Carolina, Puerto Rico, 00983
        • Site Reference ID/Investigator# 5175
      • Las Piedras, Puerto Rico, 00771
        • Site Reference ID/Investigator# 6290
      • Ponce, Puerto Rico, 00716
        • Site Reference ID/Investigator# 5179
      • Ponce, Puerto Rico, 00716
        • Site Reference ID/Investigator# 6293
      • Ponce, Puerto Rico, 00717-0634
        • Site Reference ID/Investigator# 5173
      • Ponce, Puerto Rico, 00717-1322
        • Site Reference ID/Investigator# 6300
      • Ponce, Puerto Rico, 00717-2075
        • Site Reference ID/Investigator# 5168
      • Rio Piedras, Puerto Rico, 00935
        • Site Reference ID/Investigator# 7298
      • San Juan, Puerto Rico, 00909
        • Site Reference ID/Investigator# 5170
      • San Juan, Puerto Rico, 00918
        • Site Reference ID/Investigator# 7509
      • San Juan, Puerto Rico, 00921-3201
        • Site Reference ID/Investigator# 6288
      • San Juan, Puerto Rico, 00936-5067
        • Site Reference ID/Investigator# 6291
      • Toa Baja, Puerto Rico, 00949
        • Site Reference ID/Investigator# 6919
      • Yabucoa, Puerto Rico, 00767
        • Site Reference ID/Investigator# 6296
  • Spain
      • Barcelona, Spain, 08036
        • Site Reference ID/Investigator# 6569
      • Galdakao, Spain, 48960
        • Site Reference ID/Investigator# 10621
      • L'Hospitalet de, Spain, 08907
        • Site Reference ID/Investigator# 6330
      • Madrid, Spain, 28041
        • Site Reference ID/Investigator# 5111
      • Oviedo, Spain, 33006
        • Site Reference ID/Investigator# 5110
      • Santander, Spain, 39008
        • Site Reference ID/Investigator# 6329
      • Valencia, Spain, 46017
        • Site Reference ID/Investigator# 11281
  • Taiwan
      • Hsin-Chuang City, Taiwan
        • Site Reference ID/Investigator# 6286
      • Taichung, Taiwan, 433
        • Site Reference ID/Investigator# 7927
      • Taichung City, Taiwan, 40764
        • Site Reference ID/Investigator# 8335
      • Taipei, Taiwan
        • Site Reference ID/Investigator# 6285
      • Taipei City, Taiwan, 10449
        • Site Reference ID/Investigator# 6294
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Site Reference ID/Investigator# 862
    • California
      • Fountain Valley, California, United States, 92708
        • Site Reference ID/Investigator# 864
      • Yuba City, California, United States, 95991
        • Site Reference ID/Investigator# 7291
    • Florida
      • Hudson, Florida, United States, 34667
        • Site Reference ID/Investigator# 853
      • Lauderdale Lakes, Florida, United States, 33313
        • Site Reference ID/Investigator# 867
      • Pembroke Pines, Florida, United States, 33028
        • Site Reference ID/Investigator# 857
      • West Palm Beach, Florida, United States, 33401
        • Site Reference ID/Investigator# 8901
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 7113
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Site Reference ID/Investigator# 2531
      • Evanston, Illinois, United States, 60201
        • Site Reference ID/Investigator# 3371
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site Reference ID/Investigator# 869
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Site Reference ID/Investigator# 8054
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Site Reference ID/Investigator# 854
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Site Reference ID/Investigator# 6281
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Site Reference ID/Investigator# 859
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 7214
    • New York
      • Albany, New York, United States, 12206
        • Site Reference ID/Investigator# 8046
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
        • Site Reference ID/Investigator# 866
      • Greenville, North Carolina, United States, 27834
        • Site Reference ID/Investigator# 8039
      • Morehead City, North Carolina, United States, 28557
        • Site Reference ID/Investigator# 8053
      • Winston-Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 6626
    • Pennsylvania
      • Carlisle, Pennsylvania, United States, 17015
        • Site Reference ID/Investigator# 7495
    • Texas
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 9061
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 8325
      • Dallas, Texas, United States, 75390
        • Site Reference ID/Investigator# 856
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7494
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female participant >= 20 years old.
  • Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase
  • Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
  • Participant is not expected to begin dialysis for at least 6 months.
  • If female, participant is not breast feeding or is not pregnant.

  • For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values:

    • Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula
    • Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other
    • Corrected serum calcium level <= 9.8 mg/dL
    • intact parathyroid hormone (iPTH) value between 35-500 pg/mL
    • Glycosylated hemoglobin A1c (HbA1c) <= 12%
    • Serum albumin > 3.0 g/dL
    • Negative urine pregnancy test for female participants

Exclusion Criteria:

  • Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
  • Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
  • Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
  • Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of >= 0.5 mg/dL) in serum creatinine to > 4 mg/dL.
  • Participant has chronic gastrointestinal disease.
  • Participant has secondary hypertension.
  • Participant has poorly controlled hypertension.
  • Participant has a history of kidney stones.
  • Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase.
  • Participant has evidence of poor compliance with diet or medication.
  • Participant has received any investigational drug within 30 days prior to study drug administration.
  • Participant is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium, or bone metabolism, other than calcium containing phosphate binder or female participants on stable (same dose and product for three months) estrogen and/or progestin therapy.
  • For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
  • Participant is known to be human immunodeficiency virus (HIV) positive.
  • Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Paricalcitol 1 mcg
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Drug: Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
Other Names:
  • Zemplar
  • ABT-358
  • paricalcitol
Active Comparator: Paricalcitol 2 mcg
Two paricalcitol 1 mcg capsules per dose
Drug: Zemplar (paricalcitol) capsules
Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
Other Names:
  • Zemplar
  • ABT-358
  • paricalcitol
Placebo Comparator: Placebo
Two placebo capsules per dose
Drug: Placebo
Group 1 - Placebo once daily (two placebo capsules once daily)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
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
The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
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
Change is mean change in picograms of iPTH per milliliter of serum.
Baseline (screening period) through 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dennis Andress, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M05-741
  • 2006-001363-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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