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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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1 May 2012 |
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Main ID: |
EUCTR2004-000973-69-IT |
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Date of registration:
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07/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A RANDOMIZED, OPEN-LABEL, COMPARATIVE EVALUATION OF THE SAFETY AND EFFICACY OF SIROLIMUS VERSUS CYCLOSPORINE WHEN COMBINED IN A REGIMEN CONTAINING BASILIXIMAB, MYCOPHENOLATE MOFETIL, AND CORTICOSTEROIDS IN PRIMARY DE NOVO RENAL ALLOGRAFT RECIPIENTS
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Scientific title:
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A RANDOMIZED, OPEN-LABEL, COMPARATIVE EVALUATION OF THE SAFETY AND EFFICACY OF SIROLIMUS VERSUS CYCLOSPORINE WHEN COMBINED IN A REGIMEN CONTAINING BASILIXIMAB, MYCOPHENOLATE MOFETIL, AND CORTICOSTEROIDS IN PRIMARY DE NOVO RENAL ALLOGRAFT RECIPIENTS |
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Date of first enrolment:
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23/05/2005 |
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Target sample size:
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500 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000973-69 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Hungary
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Italy
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Spain
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Sweden
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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The rationale for the present study is to assess whether a CNI-free regimen including antibody induction, sirolimus and mycophenolate mofetil MMF results in improved long-term renal function without having a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of sirolimus to reduce the severity and/or progression of Chronic allograft nephropaty CAN , wich could represent a major advance in the field of transplantation.
MedDRA version: 6.1
Level: PT
Classification code 10023439
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Intervention(s)
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Trade Name: Rapamune 30CPR RIV 1MG
Product Name: Sirolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Current Sponsor code: 0468H1-318-WW
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: Rapamune 30CPR RIV 2MG
Product Name: Sirolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Current Sponsor code: 0468H1-318-WW
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Trade Name: Rapamune OS FL 60ML + 30SIR DOS+
Product Name: Sirolimus
Product Code: 0468H1-318-WW
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Current Sponsor code: 0468H1-318-WW
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Secondary Objective:
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Primary end point(s):
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Main Objective:
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Secondary ID(s)
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0468H1-318-WW
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2004-000973-69-HU
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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