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A Study of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Being Treated With Renin-Angiotensin System Inhibitors

This study is currently recruiting participants.
Verified by Abbott, August 2008

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00421733
  Purpose

The study objective is to evaluate the effect of paricalcitol capsules on albuminuria reduction in Chronic Kidney Disease (CKD) subjects with Type 2 diabetic nephropathy receiving optimal ACEi and/or ARB therapy


Condition Intervention Phase
Diabetic Nephropathy
Chronic Kidney Disease Stages 3 & 4
Drug: Zemplar (paricalcitol ) capsules
Drug: Zemplar (paricalcitol) capsules
Drug: Placebo
Phase II

MedlinePlus related topics:   Diabetic Kidney Problems   

ChemIDplus related topics:   Vitamin D    Ergocalciferol    19-Nor-1alpha,25-dihydroxyvitamin D2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • The percent change from baseline to the last on-treatment UACR measurement using UACR levels determined from the first morning void urine collections [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects achieving at least a 15% reduction in the last on-treatment UACR levels from baseline; the change from baseline to the last on-treatment measurement in albumin determined from 24-hour urine collections. [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The change from baseline to the last on-treatment measurement in albumin determined from 24-hour urine collections [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   258
Study Start Date:   January 2007
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Paricalcitol 1 mcg: Active Comparator
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Drug: Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol capsules 1 mcg QD (one paricalcitol 1 mcg QD capsule and one matching placebo capsule QD)
Paricalcitol 2 mcg: Active Comparator
Two paricalcitol 1 mcg capsules per dose
Drug: Zemplar (paricalcitol) capsules
Group 3 - paricalcitol capsules 2 mcg QD (two paricalcitol 1 mcg capsules QD)
Placebo: Placebo Comparator
Two placebo capsules per dose
Drug: Placebo
Group 1 - Placebo QD (two placebo capsules QD)

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male or female subjects >= 20 years old.
  • Subject 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
  • Subject 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, subject may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
  • Subject is not expected to begin dialysis for at least 6 months.
  • If female, subject is not breast feeding or is not pregnant.
  • For entry into the Treatment Phase the subject must satisfy the following criteria based on the Screening laboratory values:

    • Estimated GFR between 15-90 mL/min/1.73m2 by simplified MDRD formula
    • 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
    • iPTH value between 35-500 pg/mL
    • HbA1c <= 12%
    • Serum albumin > 3.0 g/dL
    • Negative urine pregnancy test for female subjects

Exclusion Criteria:

  • Subject has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
  • Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
  • Subject has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
  • Subject has had acute renal failure within 12 weeks of the Screening Phase.
  • Subject has chronic gastrointestinal disease.
  • Subject has secondary hypertension.
  • Subject has poorly controlled hypertension.
  • Subject has a history of kidney stones.
  • Subject has a history of drug or alcohol abuse within six months prior to the Screening Phase.
  • Subject has evidence of poor compliance with diet or medication.
  • Subject has received any investigational drug within 30 days prior to study drug administration.
  • Subject 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 subjects on stable (same dose and product for three months) estrogen and/or progestin therapy.
  • For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
  • Subject is known to be HIV positive.
  • Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421733

Contacts
Contact: Mark Holst     847-936-0809     mark.holst@abbott.com    
Contact: Dennis Andress, MD     847-936-3555     dennis.andress@abbott.com    

Show 71 study locations  Show 71 Study Locations

Sponsors and Collaborators
Abbott

Investigators
Study Director:     Paul Audhya, MD     Abbott    
  More Information


Responsible Party:   Abbott ( Dennis Andress, MD )
Study ID Numbers:   M05-741, EudraCT: 2006-001363-31
First Received:   January 10, 2007
Last Updated:   September 18, 2008
ClinicalTrials.gov Identifier:   NCT00421733
Health Authority:   United States: Food and Drug Administration

Keywords provided by Abbott:
Type 2 Diabetic Nephropathy  

Study placed in the following topic categories:
Renal Insufficiency
Diabetic Nephropathies
Albuminuria
Urination Disorders
Ergocalciferols
Kidney Failure, Chronic
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Proteinuria
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Endocrinopathy
Kidney Diseases
Diabetes Complications
Kidney Failure

Additional relevant MeSH terms:
Urological Manifestations
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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