이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2011년 5월 31일 업데이트: 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)

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

81

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Athens, 그리스
        • Novartis
  • 대만
      • Taichung, 대만
        • Novartis
  • 독일
      • Berlin, 독일
        • Novartis
      • Tubingen, 독일
        • Novartis
  • 스페인
      • Barcelona, 스페인
        • Novartis
      • Madrid, 스페인
        • Novartis
  • 영국
      • Cambridge, 영국
        • Novartis
  • 이탈리아
      • Brescia, 이탈리아
        • Novartis
      • Ferrara, 이탈리아
        • Novartis
      • Milano, 이탈리아
        • Novartis
      • Padova, 이탈리아
        • Novartis
  • 콜롬비아
      • Bogota, 콜롬비아
        • Novartis
  • 프랑스
      • Creteil, 프랑스
        • Novartis
      • Nantes, 프랑스
        • Novartis
      • Paris, 프랑스
        • Novartis Investigative Site
  • 헝가리
      • Budapest, 헝가리
        • Novartis
      • Debrecen, 헝가리
        • Novartis

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
다른 이름들:
  • 마이포틱
의약품: Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
의약품: Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
활성 비교기: 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.
의약품: Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
다른 이름들:
  • 마이포틱
의약품: Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
의약품: Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Patients With Complete Remission
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Patients With Complete Remission
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 2월 1일

기본 완료 (실제)

2009년 11월 1일

연구 완료 (실제)

2009년 11월 1일

연구 등록 날짜

최초 제출

2007년 1월 16일

QC 기준을 충족하는 최초 제출

2007년 1월 16일

처음 게시됨 (추정)

2007년 1월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 6월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 5월 31일

마지막으로 확인됨

2011년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CERL080A2420

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

루푸스 신염에 대한 임상 시험

Mycophenolate sodium에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cote d'Ivoire

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다