A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
NCT ID: NCT01363752
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
853 participants
INTERVENTIONAL
2011-03-08
2013-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Advagraf + MMF + Steroids
Without sirolimus
Advagraf
oral
Mycophenolate Mofetil
oral
Corticosteroids
i.v. and oral
Advagraf + MMF + Steroids + Sirolimus
With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28
Advagraf
oral
Mycophenolate Mofetil
oral
Sirolimus
oral
Corticosteroids
i.v. and oral
Interventions
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Advagraf
oral
Mycophenolate Mofetil
oral
Sirolimus
oral
Corticosteroids
i.v. and oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen \[HLA\] identical) donor with compatible ABO blood type
* Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
* Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Exclusion Criteria
* Cold ischemia time of the donor kidney \> 30 hours
* Panel Reactive Antibody (PRA) \>20%
* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
* Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
* Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
* Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Pregnant woman or breast-feeding mother
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
* Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
* Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
* Unlikely to comply with the visits scheduled in the protocol
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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5042
New Lambton, , Australia
5043
Perth, , Australia
1141
Innsbruck, , Austria
1142
Linz, , Austria
1140
Vienna, , Austria
3240
Minsk, , Belarus
1241
Leuven, , Belgium
1240
Liège, , Belgium
Site 1441
Brno, , Czechia
1440
Ostrava - Poruba, , Czechia
1752
Amiens, , France
1740
Brest, , France
1742
Clermont-Ferrand, , France
1746
Créteil, , France
1750
Dijon, , France
1741
Le Kremilin Bicetre Cedex, , France
1749
Paris, , France
1751
Toulouse, , France
1748
Tours, , France
1745
Vandœuvre-lès-Nancy, , France
1541
Bochum, , Germany
1542
Erlangen, , Germany
1543
Essen, , Germany
1544
Frankfurt, , Germany
1545
Hannoversch Münden, , Germany
1540
Hanover, , Germany
1546
Heidelberg, , Germany
1547
Kiel, , Germany
1548
Leipzig, , Germany
1549
München, , Germany
1550
Münster, , Germany
5441
Hong Kong, , Hong Kong
1940
Budapest, , Hungary
2144
Palermo, , Italy
2143
Roma, , Italy
2140
Siena, , Italy
2440
Maastricht, , Netherlands
2643
Katowice, , Poland
2640
Lodz, , Poland
2641
Poznan, , Poland
2841
Kemerovo, , Russia
2843
Moscow, , Russia
2842
Omsk, , Russia
2840
Vol'ginskiy, , Russia
5245
Busan, , South Korea
5243
Daegu, , South Korea
5242
Seoul, , South Korea
5241
Seoul, , South Korea
5244
Seoul, , South Korea
1640
Alicante, , Spain
1641
Barcelona, , Spain
1643
Santander, , Spain
1642
Vizcaya, , Spain
5343
Tainan City, , Taiwan
5342
Taoyuan District, , Taiwan
3042
Istanbul, , Turkey (Türkiye)
3043
Istanbul, , Turkey (Türkiye)
3044
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2010-019639-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PMR-EC-1212
Identifier Type: -
Identifier Source: org_study_id
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