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

Sponsor:	Abbott
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00421733

Purpose

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.

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

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems Kidney Failure Urine and Urination Vitamin D

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Change is mean change in picograms of iPTH per milliliter of serum.

Enrollment:	281
Study Start Date:	December 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: ABT-358 paricalcitol Zemplar
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: ABT-358 paricalcitol Zemplar
Placebo Comparator: Placebo Two placebo capsules per dose	Drug: Placebo Group 1 - Placebo once daily (two placebo capsules once daily) Other Name: placebo

Eligibility

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

Criteria

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.

Contacts and Locations

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

Show 72 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Dennis Andress, MD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Abbott:

Type 2 Diabetic Nephropathy

Additional relevant MeSH terms:

Albuminuria
Diabetic Nephropathies
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Diabetes Complications

Diabetes Mellitus
Endocrine System Diseases
Renal Insufficiency
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012