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
Overview
- Phase
- Phase 2
- Intervention
- Zemplar (paricalcitol ) capsules
- Conditions
- Diabetic Nephropathy
- Sponsor
- Abbott
- Enrollment
- 281
- Locations
- 72
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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 receptor blocker (ARB) therapy.
Investigators
Eligibility 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
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.
Arms & Interventions
Paricalcitol 1 mcg
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Intervention: Zemplar (paricalcitol ) capsules
Paricalcitol 2 mcg
Two paricalcitol 1 mcg capsules per dose
Intervention: Zemplar (paricalcitol) capsules
Placebo
Two placebo capsules per dose
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.(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.(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.(Baseline (screening period) through 24 weeks of treatment)