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Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

2011年5月31日 更新者：Novartis Pharmaceuticals

A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

81

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 匈牙利
      • Budapest、匈牙利
        • Novartis
      • Debrecen、匈牙利
        • Novartis
  • 台湾
      • Taichung、台湾
        • Novartis
  • 哥伦比亚
      • Bogota、哥伦比亚
        • Novartis
  • 希腊
      • Athens、希腊
        • Novartis
  • 德国
      • Berlin、德国
        • Novartis
      • Tubingen、德国
        • Novartis
  • 意大利
      • Brescia、意大利
        • Novartis
      • Ferrara、意大利
        • Novartis
      • Milano、意大利
        • Novartis
      • Padova、意大利
        • Novartis
  • 法国
      • Creteil、法国
        • Novartis
      • Nantes、法国
        • Novartis
      • Paris、法国
        • Novartis Investigative Site
  • 英国
      • Cambridge、英国
        • Novartis
  • 西班牙
      • Barcelona、西班牙
        • Novartis
      • Madrid、西班牙
        • Novartis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria

  • Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification criteria)
  • Aged ≥18 years,
  • Proliferative lupus nephritis classified as ISN/RPS class III or IV
  • Renal biopsy within the last 24-month preceding the study entry
  • Proteinuria defined as >0.5 gram urine protein per gram urine creatinine at screening and baseline
  • Clinical activity defined by one or more of the following changes in renal function: Serum creatinine >1.0 mg/dl (88.4 μmol/l)
  • Microscopic hematuria defined as >5 red cells per high power field
  • Presence of cellular casts

Exclusion criteria

  • Patients with calculated creatinine clearance <30 ml/min (using the Cockcroft-Gault formula)
  • Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months,
  • Patients having received oral or i.v. cyclophosphamide during the last 3 month
  • Patients having received mycophenolate mofetil (MMF) within the preceding 3 months
  • Use of any antibody therapy within the past 6 months
  • Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study.
  • Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures,
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Standard dose
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
药品：Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
其他名称：
  • Myfortic
药品：Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
药品：Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
有源比较器：Low dose
Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
药品：Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
其他名称：
  • Myfortic
药品：Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
药品：Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Patients With Complete Remission
大体时间：24 Weeks
Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.
24 Weeks

次要结果测量

结果测量
措施说明
大体时间
Number of Patients With Complete Remission
大体时间：12 Weeks
Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.
12 Weeks
Number of Patients With Partial Remission
大体时间：Baseline to 12 and 24 weeks
Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.
Baseline to 12 and 24 weeks
Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
大体时间：12 Weeks and 24 Weeks
Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.
12 Weeks and 24 Weeks
Number of Patients With Moderate to Severe Flares
大体时间：12 and 24 weeks
A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)
12 and 24 weeks
Duration of Exposure to Study Medication
大体时间：24 weeks
The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.
24 weeks
Number of Patients With Adverse Events and Infections
大体时间：24 weeks
Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
24 weeks
Number of Patients With Treatment Failure
大体时间：12 Weeks and 24 Weeks
Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.
12 Weeks and 24 Weeks
Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
大体时间：From Baseline to week 4, week 12 and week 24
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.
From Baseline to week 4, week 12 and week 24
Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
大体时间：From Baseline to week 4, week 12 and week 24
BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].
From Baseline to week 4, week 12 and week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年2月1日

初级完成 (实际的)

2009年11月1日

研究完成 (实际的)

2009年11月1日

研究注册日期

首次提交

2007年1月16日

首先提交符合 QC 标准的

2007年1月16日

首次发布 (估计)

2007年1月17日

研究记录更新

最后更新发布 (估计)

2011年6月28日

上次提交的符合 QC 标准的更新

2011年5月31日

最后验证

2011年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CERL080A2420

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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