Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
NCT ID: NCT01544491
Last Updated: 2019-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2012-08-17
2018-09-24
Brief Summary
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This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational arm
Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
RAD001
Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
Control arm
MMF continuation (in combination with tacrolimus and standard dose steroids)
MMF
MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids
Interventions
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RAD001
Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
MMF
MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids
Eligibility Criteria
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Inclusion Criteria
2. Primary or secondary paediatric kidney transplant recipient aged greater than or equal to 1 year and younger than 18 years receiving a deceased donor or non-HLA identical living donor (related or unrelated) renal transplant.
1. Patients on TAC + MMF + steroids.
2. Renal function with eGFR \> 40 ml/min/1.73 m2 (Schwartz formula - abbreviated).
Exclusion Criteria
2. Recipients of a kidney with a cold ischemia time \> 24 hours.
3. History of hypersensitivity or contraindications to any of the study drugs or to drugs of similar chemical classes, or to any of the excipients.
4. History of malignancy of any organ system treated or untreated, carrying possible risk of recurrence according to current guidelines (Appendix 10 of protocol).
1. Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives prior randomization, whichever is longer.
2. Patients with ongoing or recently (within 2 weeks prior to randomization) treated episodes of acute rejection (any grade) or a steroid resistant acute rejection at the time of randomization.
3. Patients who experienced acute cellular rejection (Banff ≥1B) or any antibody mediated acute rejection or patients considered at high risk of antibody mediated acute rejection by the investigator assessment (e.g. presence of newly formed DSA, histological suspicion) at any time before randomization (as the DSA quantitative threshold to define high risk is not fully established, the assessment of the risk will be made after discussion between the laboratory expert and the investigator who will take into account all information available and apply best judgment).
4. Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the investigator.
5. Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and can not discontinue the treatment (see Appendix 6 for list of medications).
6. Patients with nephrotic range proteinuria (protein to creatinine ratio ≥2.0 mg/mg or 200 mg/mmol (Hogg, 2003).
1 Year
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Santa Fe, , Argentina
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Bron, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Roma, ITA, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Esplugues de Llobregat, Barcelona, Spain
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Antalya, , Turkey (Türkiye)
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Nottingham, , United Kingdom
Countries
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References
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Patry C, Sauer LD, Sander A, Krupka K, Fichtner A, Brezinski J, Geissbuhler Y, Aubrun E, Grinienko A, Strologo LD, Haffner D, Oh J, Grenda R, Pape L, Topaloglu R, Weber LT, Bouts A, Kim JJ, Prytula A, Konig J, Shenoy M, Hocker B, Tonshoff B. Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry. Pediatr Nephrol. 2023 May;38(5):1621-1632. doi: 10.1007/s00467-022-05777-x. Epub 2022 Oct 20.
Tonshoff B, Tedesco-Silva H, Ettenger R, Christian M, Bjerre A, Dello Strologo L, Marks SD, Pape L, Veldandi U, Lopez P, Cousin M, Pandey P, Meier M. Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal. Am J Transplant. 2021 Jan;21(1):123-137. doi: 10.1111/ajt.16005. Epub 2020 Jun 27.
Other Identifiers
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2010-024381-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001A2314
Identifier Type: -
Identifier Source: org_study_id
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