Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
NCT ID: NCT01950819
Last Updated: 2019-01-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
2037 participants
INTERVENTIONAL
2013-12-03
2018-01-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
NCT01936519
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
NCT00332839
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
NCT01025817
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
NCT00154310
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EVR+rCNI
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Induction therapy
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Corticosteroids
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
EVR+rCNI
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
MPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Induction therapy
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Corticosteroids
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
MPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Induction therapy
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Corticosteroids
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
EVR+rCNI
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
MPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject randomized within 24 hr of completion of transplant surgery.
3. Recipient of a kidney with a cold ischemia time \< 30 hours.
4. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
Exclusion Criteria
2. Use of other investigational drugs at the time of enrollment.
3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
4. Multi-organ transplant recipient.
5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
7. Subject who is HIV-positive.
8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
10. Subject with a BMI greater than 35.
11. Subject with severe systemic infections, current or within the two weeks prior to randomization.
12. Subject requiring systemic anticoagulation.
13. History of malignancy of any organ system.
14. Subject with severe restrictive or obstructive pulmonary disorders.
15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
16. Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
17. Pregnant or nursing (lactating) women.
18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Loma Linda, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Burlington, Massachusetts, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Livingston, New Jersey, United States
Novartis Investigative Site
Buffalo, New York, United States
Novartis Investigative Site
The Bronx, New York, United States
Novartis Investigative Site
Chapel Hill, North Carolina, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Winston-Salem, North Carolina, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Harrisburg, Pennsylvania, United States
Novartis Investigative Site
Providence, Rhode Island, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Fort Worth, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Charlottesville, Virginia, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
Milwaukee, Wisconsin, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
San Martín, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Corrientes, , Argentina
Novartis Investigative Site
Córdoba, , Argentina
Novartis Investigative Site
Córdoba, , Argentina
Novartis Investigative Site
Santa Fe, , Argentina
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Randwick, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Murdoch, Western Australia, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Novartis Investigative Site
Linz, , Austria
Novartis Investigative Site
Edegem, Antwerpen, Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Sofia, BGR, Bulgaria
Novartis Investigative Site
Santiago, , Chile
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia
Novartis Investigative Site
Bogotá, , Colombia
Novartis Investigative Site
Rijeka, , Croatia
Novartis Investigative Site
Zagreb, , Croatia
Novartis Investigative Site
Zagreb, , Croatia
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Al Mansurah, , Egypt
Novartis Investigative Site
Nice, Cedex1, France
Novartis Investigative Site
Tours, Indre Et Loire, France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Reims, , France
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hannover Muenden, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Kaiserslautern, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Thessaloniki, GR, Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Pátrai, , Greece
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Vellore, Tamil Nadu, India
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Parma, PR, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Siena, SI, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Novara, , Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Toyoake, Aichi-ken, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Kuwait City, , Kuwait
Novartis Investigative Site
El Achrafiyé, , Lebanon
Novartis Investigative Site
Saida, , Lebanon
Novartis Investigative Site
Saida, , Lebanon
Novartis Investigative Site
Kuala Lumpur, , Malaysia
Novartis Investigative Site
Selangor Darul Ehsan, , Malaysia
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Maastricht, AZ, Netherlands
Novartis Investigative Site
Utrecht, The Netherlands, Netherlands
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Nijmegen, , Netherlands
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Szczecin, Pomeranian Voivodeship, Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Carnaxide, Lisbon District, Portugal
Novartis Investigative Site
Coimbra, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Krasnodar, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Nizhny Novgorod, , Russia
Novartis Investigative Site
Volzhskiy, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Novartis Investigative Site
Dammam, , Saudi Arabia
Novartis Investigative Site
Jeddah, , Saudi Arabia
Novartis Investigative Site
Riyadh, , Saudi Arabia
Novartis Investigative Site
Belgrade, , Serbia
Novartis Investigative Site
Niš, , Serbia
Novartis Investigative Site
Novi Sad, , Serbia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Banská Bystrica, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Martin, , Slovakia
Novartis Investigative Site
Ljubljana, , Slovenia
Novartis Investigative Site
Cape Town, Western Province, South Africa
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Zaragoza, , Spain
Novartis Investigative Site
Gothenburg, , Sweden
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Tainan City, Taiwan ROC, Taiwan
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Ratchathewi, Bangkok, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Antalya, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Mecidiyekoy/Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.
Watarai Y, Danguilan R, Casasola C, Chang SS, Ruangkanchanasetr P, Kee T, Wong HS, Kenmochi T, Amante AJ, Shu KH, Ingsathit A, Bernhardt P, Hernandez-Gutierrez MP, Han DJ, Kim MS. Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study. Clin Transplant. 2021 Oct;35(10):e14415. doi: 10.1111/ctr.14415. Epub 2021 Sep 23.
Citterio F, Henry M, Kim DY, Kim MS, Han DJ, Kenmochi T, Mor E, Tisone G, Bernhardt P, Hernandez Gutierrez MP, Watarai Y. Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study. Expert Opin Drug Saf. 2020 Oct;19(10):1339-1348. doi: 10.1080/14740338.2020.1792441. Epub 2020 Jul 20.
Berger SP, Sommerer C, Witzke O, Tedesco H, Chadban S, Mulgaonkar S, Qazi Y, de Fijter JW, Oppenheimer F, Cruzado JM, Watarai Y, Massari P, Legendre C, Citterio F, Henry M, Srinivas TR, Vincenti F, Gutierrez MPH, Marti AM, Bernhardt P, Pascual J; TRANSFORM investigators. Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study. Am J Transplant. 2019 Nov;19(11):3018-3034. doi: 10.1111/ajt.15480. Epub 2019 Jul 1.
Pascual J, Berger SP, Witzke O, Tedesco H, Mulgaonkar S, Qazi Y, Chadban S, Oppenheimer F, Sommerer C, Oberbauer R, Watarai Y, Legendre C, Citterio F, Henry M, Srinivas TR, Luo WL, Marti A, Bernhardt P, Vincenti F; TRANSFORM Investigators. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation. J Am Soc Nephrol. 2018 Jul;29(7):1979-1991. doi: 10.1681/ASN.2018010009. Epub 2018 May 11.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-000322-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001A2433
Identifier Type: -
Identifier Source: org_study_id
NCT02316938
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.