NCT01224028已完成2 期
Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
研究概览
简要总结
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IgA nephropathy confirmed by renal biopsy
- •Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD: Modification of Diet in Renal Disorder)
- •UACR level between 0.3 and 3.0
- •Blood pressure measurements < 130/80mmHg
排除标准
- •Use of immunosuppressants for more than two weeks within last one month
- •Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue & additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker
- •Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
- •Hypersensitivity to the investigational drug or macrolide agents
- •Use of potassium-sparing diuretics
- •Persistence of liver function abnormality more than 1 month or presence of acute active hepatitis
- •Other investigational drug within last 30 days
研究组 & 干预措施
Tacrolimus group
Experimental
干预措施: Tacrolimus (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
时间窗: Week 0, week 12 and week 16
次要结局
- Proportion of subjects achieving more than 30% reduction of UACR level from baseline(Week 0 and week 16)
- Composite event rate achieving less than 0.2 or 50% reduction of UACR level(Week 0 and week 16)
- Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests(Through week 16)
- Proportion of subjects achieving more than 50% reduction of UACR level from baseline(Week 0 and week 16)
- Proportion of subjects achieving more than 0.2 reduction of UACR level(Week 0 and week 16)
- Changes of UACR measured between before the study and each visit(Week 0, week 4, week 8, week 12 and week 16)
研究者
相似试验
已完成
4 期
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenNephrotic SyndromeNCT01162005Seoul National University Hospital77
已完成
3 期
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)Kidney DiseasesTacrolimusNephrotic SyndromeNCT00615667Sun Yat-sen University61
尚未招募
2 期
Double blind, placebo controlled study Tacrolimus versus Emmolient in localized sclerodermamorphoea10010761localized sclerodermaNL-OMON31329niversitair Medisch Centrum Sint Radboud20
已完成
不适用
A randomized controlled study of tacrolimus for the treatment of idiopathic membranous nephropathyIdiopathic membranous nephropathyUrological and Genital DiseasesISRCTN17977921The First Affiliated Hospital of Zhengzhou University (China)120
招募中
不适用
Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitisulcerative colitisJPRN-UMIN000005824Juntendo University20