NCT00421733已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 281
- 试验地点
- 72
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Paricalcitol 1 mcg
Active Comparator
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
干预措施: Zemplar (paricalcitol ) capsules (Drug)
Paricalcitol 2 mcg
Active Comparator
Two paricalcitol 1 mcg capsules per dose
干预措施: Zemplar (paricalcitol) capsules (Drug)
Placebo
Placebo Comparator
Two placebo capsules per dose
干预措施: Placebo (Drug)
结局指标
主要结局
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).
时间窗: 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.
次要结局
- 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)
研究者
研究点 (72)
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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 Sytem Inhibitors - Not availableType 2 diabetic nephropathyMedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseEUCTR2006-001363-31-DEAbbott GmbH & Co KG258