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Diabetic NephropathyPhase 2VITALNCT00421733

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

A Phase 2 study testing Zemplar (paricalcitol ) capsules and Zemplar (paricalcitol) capsules in people with Diabetic Nephropathy and Chronic Kidney Disease, run by Abbott at 72 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetic Nephropathy, Chronic Kidney Disease
What is being tested?
Zemplar (paricalcitol ) capsules and Zemplar (paricalcitol) capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
281 participants
Where
72 sitesin 10 countries
Study dates
Dec 2006to Jun 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

72 sites in 10 countries.

72 sites in 10 countries

United States27 sites

  • Site Reference ID/Investigator# 8046

    Albany, New York, 12206

  • Site Reference ID/Investigator# 8054

    Baton Rouge, Louisiana, 70808

  • Site Reference ID/Investigator# 6281

    Boston, Massachusetts, 02215

  • Site Reference ID/Investigator# 859

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 7495

    Carlisle, Pennsylvania, 17015

  • Site Reference ID/Investigator# 866

    Charlotte, North Carolina, 28208

  • Site Reference ID/Investigator# 2531

    Chicago, Illinois, 60654

  • Site Reference ID/Investigator# 9061

    Dallas, Texas, 75230

  • Site Reference ID/Investigator# 8325

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 856

    Dallas, Texas, 75390

  • Site Reference ID/Investigator# 3371

    Evanston, Illinois, 60201

  • Site Reference ID/Investigator# 864

    Fountain Valley, California, 92708

  • Site Reference ID/Investigator# 8039

    Greenville, North Carolina, 27834

  • Site Reference ID/Investigator# 853

    Hudson, Florida, 34667

  • Site Reference ID/Investigator# 869

    Indianapolis, Indiana, 46202

  • Site Reference ID/Investigator# 867

    Lauderdale Lakes, Florida, 33313

  • Site Reference ID/Investigator# 8053

    Morehead City, North Carolina, 28557

  • Site Reference ID/Investigator# 7214

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 857

    Pembroke Pines, Florida, 33028

  • Site Reference ID/Investigator# 862

    Phoenix, Arizona, 85012

  • Site Reference ID/Investigator# 854

    Rockville, Maryland, 20852

  • Site Reference ID/Investigator# 7113

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 7494

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 774

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 8901

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 6626

    Winston-Salem, North Carolina, 27103

  • Site Reference ID/Investigator# 7291

    Yuba City, California, 95991

Other trials in United States

Puerto Rico15 sites

  • Site Reference ID/Investigator# 6916

    Caguas, 00725

  • Site Reference ID/Investigator# 5175

    Carolina, 00983

  • Site Reference ID/Investigator# 6290

    Las Piedras, 00771

  • Site Reference ID/Investigator# 5179

    Ponce, 00716

  • Site Reference ID/Investigator# 6293

    Ponce, 00716

  • Site Reference ID/Investigator# 5173

    Ponce, 00717-0634

  • Site Reference ID/Investigator# 6300

    Ponce, 00717-1322

  • Site Reference ID/Investigator# 5168

    Ponce, 00717-2075

  • Site Reference ID/Investigator# 7298

    Rio Piedras, 00935

  • Site Reference ID/Investigator# 5170

    San Juan, 00909

  • Site Reference ID/Investigator# 7509

    San Juan, 00918

  • Site Reference ID/Investigator# 6288

    San Juan, 00921-3201

  • Site Reference ID/Investigator# 6291

    San Juan, 00936-5067

  • Site Reference ID/Investigator# 6919

    Toa Baja, 00949

  • Site Reference ID/Investigator# 6296

    Yabucoa, 00767

Other trials in Puerto Rico

Spain7 sites

  • Site Reference ID/Investigator# 6569

    Barcelona, 08036

  • Site Reference ID/Investigator# 10621

    Galdakao, 48960

  • Site Reference ID/Investigator# 6330

    L'Hospitalet de, 08907

  • Site Reference ID/Investigator# 5111

    Madrid, 28041

  • Site Reference ID/Investigator# 5110

    Oviedo, 33006

  • Site Reference ID/Investigator# 6329

    Santander, 39008

  • Site Reference ID/Investigator# 11281

    Valencia, 46017

Other trials in Spain

Taiwan5 sites

  • Site Reference ID/Investigator# 8335

    Taichung, 40764

  • Site Reference ID/Investigator# 7927

    Taichung, 433

  • Site Reference ID/Investigator# 6294

    Taipei, 10449

  • Site Reference ID/Investigator# 6285

    Taipei

  • Site Reference ID/Investigator# 6286

    Xinzhuang

Other trials in Taiwan

Greece4 sites

  • Site Reference ID/Investigator# 6314

    Athens, 18454

  • Site Reference ID/Investigator# 6306

    Ioannina, 45500

  • Site Reference ID/Investigator# 5631

    Thessaloniki, 54636

  • Site Reference ID/Investigator# 6310

    Thessaloniki, 54642

Other trials in Greece

Italy4 sites

  • Site Reference ID/Investigator# 6312

    Bergamo, 24128

  • Site Reference ID/Investigator# 6303

    Brescia, 25123

  • Site Reference ID/Investigator# 6309

    Milan, 20142

  • Site Reference ID/Investigator# 6210

    Modena, 41100

Other trials in Italy

Poland4 sites

  • Site Reference ID/Investigator# 6304

    Bydgoszcz, 85-094

  • Site Reference ID/Investigator# 5622

    Katowice, 40027

  • Site Reference ID/Investigator# 5203

    Szczecin, 70-111

  • Site Reference ID/Investigator# 6315

    Warsaw, 00909

Other trials in Poland

Germany3 sites

  • Site Reference ID/Investigator# 6316

    Düsseldorf, 40210

  • Site Reference ID/Investigator# 5167

    Hanover, 30625

  • Site Reference ID/Investigator# 6302

    Ludwigshafen, 67059

Other trials in Germany

Portugal2 sites

  • Site Reference ID/Investigator# 6327

    Lisbon, 1069-166

  • Site Reference ID/Investigator# 6326

    Porto, 4202-451

Other trials in Portugal

Netherlands1 site

  • Site Reference ID/Investigator# 6207

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Zemplar (paricalcitol ) capsules, Zemplar (paricalcitol) capsules, Placebo
Keywords
Type 2 Diabetic Nephropathy
Medical subject headings
Diabetic Nephropathies, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zemplar (paricalcitol ) capsulesDrug

    Also called ABT-358, paricalcitol, Zemplar

    Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)

  • Zemplar (paricalcitol) capsulesDrug

    Also called ABT-358, paricalcitol, Zemplar

    Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)

  • PlaceboDrug

    Group 1 - Placebo once daily (two placebo capsules once daily)

Study groups in NCT00421733
Study groupRoleWhat they receive
Paricalcitol 1 mcgActive comparatorOne paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Receives: Drug: Zemplar (paricalcitol ) capsules
Paricalcitol 2 mcgActive comparatorTwo paricalcitol 1 mcg capsules per dose
Receives: Drug: Zemplar (paricalcitol) capsules
PlaceboPlacebo comparatorTwo placebo capsules per dose
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    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.

    Measured: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Secondary outcomes (3)

  1. Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.

    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.

    Measured: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

  2. Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.

    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.

    Measured: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

  3. Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.

    Change is mean change in picograms of iPTH per milliliter of serum.

    Measured: Baseline (screening period) through 24 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421733
Sponsor's protocol ID
M05-741
Other IDs
2006-001363-31
Acronym
VITAL
Status last verified
Jan 2012
First submitted
10 Jan 2007
Last updated
20 Jan 2012
Data monitoring committee
No

Publications

  • Coyne DW, Andress DL, Amdahl MJ, Ritz E, de Zeeuw D. Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study. Nephrol Dial Transplant. 2013 Sep;28(9):2260-8. doi: 10.1093/ndt/gft227. Epub 2013 Jun 19.

    PubMed 23787544

  • 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. doi: 10.1016/S0140-6736(10)61032-X.

    PubMed 21055801

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zemplar (paricalcitol ) capsules and Zemplar (paricalcitol) capsules in people with Diabetic Nephropathy and Chronic Kidney Disease, run by Abbott at 72 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Puerto Rico, Spain, Taiwan, Greece and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421733, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.

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