Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (TRANSFORM)

January 9, 2019 updated by: Novartis Pharmaceuticals

A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2037

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, W3400ABH
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KEH
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KET
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EPV
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1181ACH
        • Novartis Investigative Site
      • San Martin, Buenos Aires, Argentina, C1107BEA
        • Novartis Investigative Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
      • Randwick, New South Wales, Australia, 2031
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Novartis Investigative Site
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
      • Linz, Austria, A-4010
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brazil, 05403 000
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 04038-002
        • Novartis Investigative Site
    • BGR
      • Sofia, BGR, Bulgaria, 1431
        • Novartis Investigative Site
      • Santiago, Chile, 8207257
        • Novartis Investigative Site
      • Bogota, Colombia
        • Novartis Investigative Site
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Novartis Investigative Site
      • Rijeka, Croatia, 51000
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Novartis Investigative Site
      • Zagreb, Croatia, 1000
        • Novartis Investigative Site
      • Brno, Czechia, 656 91
        • Novartis Investigative Site
      • Praha 4, Czechia, 140 00
        • Novartis Investigative Site
      • Mansoura, Egypt
        • Novartis Investigative Site
      • Montpellier Cedex 5, France, 34295
        • Novartis Investigative Site
      • Paris cedex 15, France, 75015
        • Novartis Investigative Site
      • Reims, France, 51092
        • Novartis Investigative Site
    • Cedex1
      • Nice, Cedex1, France, 06001
        • Novartis Investigative Site
    • Indre Et Loire
      • Tours Cedex 9, Indre Et Loire, France, 37044
        • Novartis Investigative Site
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Hannover Muenden, Germany, 34346
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Kaiserslautern, Germany, 67655
        • Novartis Investigative Site
      • Koeln, Germany, 51109
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Muenchen, Germany, 81675
        • Novartis Investigative Site
      • München, Germany, 81377
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site
      • Athens, Greece, 11527
        • Novartis Investigative Site
      • Athens, Greece, 106 76
        • Novartis Investigative Site
      • Patras, Greece, 265 00
        • Novartis Investigative Site
    • GR
      • Thessaloniki, GR, Greece, 546 42
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110 017
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 055
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 016
        • Novartis Investigative Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Tel Aviv, Israel, 64239
        • Novartis Investigative Site
      • Novara, Italy, 28100
        • Novartis Investigative Site
    • BA
      • Bari, BA, Italy, 70124
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20162
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
      • Roma, RM, Italy, 00144
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
    • Aichi
      • Nagoya-city, Aichi, Japan, 466-8650
        • Novartis Investigative Site
      • Toyoake city, Aichi, Japan, 470 1192
        • Novartis Investigative Site
    • Chiba
      • Chiba-city, Chiba, Japan, 260-8712
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Kuwait, Kuwait
        • Novartis Investigative Site
      • Ashrafieh, Lebanon, 166830
        • Novartis Investigative Site
      • Saida, Lebanon, 652
        • Novartis Investigative Site
      • Saida, Lebanon
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia, 50589
        • Novartis Investigative Site
      • Selangor Darul Ehsan, Malaysia, 68100
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44610
        • Novartis Investigative Site
      • Amsterdam, Netherlands, 1105 AZ
        • Novartis Investigative Site
      • Groningen, Netherlands
        • Novartis Investigative Site
      • Leiden, Netherlands, 2333 ZA
        • Novartis Investigative Site
      • Nijmegen, Netherlands
        • Novartis Investigative Site
    • AZ
      • Maastricht, AZ, Netherlands, 5800
        • Novartis Investigative Site
    • The Netherlands
      • Utrecht, The Netherlands, Netherlands, 3508 GA
        • Novartis Investigative Site
      • Oslo, Norway, 0424
        • Novartis Investigative Site
      • Quezon City, Philippines, 1101
        • Novartis Investigative Site
      • Gdansk, Poland, 80 952
        • Novartis Investigative Site
      • Poznan, Poland, 60-355
        • Novartis Investigative Site
      • Poznan, Poland, 60-479
        • Novartis Investigative Site
    • Pomorskie
      • Szczecin, Pomorskie, Poland, 70-111
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000 075
        • Novartis Investigative Site
      • Lisboa, Portugal, 1600190
        • Novartis Investigative Site
      • Lisbon, Portugal, 1069-166
        • Novartis Investigative Site
      • Porto, Portugal, 4200 319
        • Novartis Investigative Site
    • Lisboa
      • Carnaxide, Lisboa, Portugal, 2790-134
        • Novartis Investigative Site
      • Ekaterinburg, Russian Federation, 620109
        • Novartis Investigative Site
      • Krasnodar, Russian Federation, 350086
        • Novartis Investigative Site
      • Moscow, Russian Federation, 123182
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129010
        • Novartis Investigative Site
      • Nizhnii Novgorod, Russian Federation, 603000
        • Novartis Investigative Site
      • Volzhskiy, Russian Federation, 404120
        • Novartis Investigative Site
      • Dammam, Saudi Arabia, 15215
        • Novartis Investigative Site
      • Jeddah, Saudi Arabia, 21499
        • Novartis Investigative Site
      • Riyadh, Saudi Arabia, 11159
        • Novartis Investigative Site
      • Belgrade, Serbia, 11000
        • Novartis Investigative Site
      • Nis, Serbia, 18000
        • Novartis Investigative Site
      • Novi Sad, Serbia
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
      • Banská Bystrica, Slovakia, 97517
        • Novartis Investigative Site
      • Bratislava, Slovakia, 833 05
        • Novartis Investigative Site
      • Kosice, Slovakia, 04166
        • Novartis Investigative Site
      • Martin, Slovakia, 03659
        • Novartis Investigative Site
      • Ljubljana, Slovenia, 1000
        • Novartis Investigative Site
    • Western Province
      • Cape Town, Western Province, South Africa, 7925
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
    • Andalucia
      • Granada, Andalucia, Spain, 18014
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Novartis Investigative Site
      • Göteborg, Sweden, SE-413 45
        • Novartis Investigative Site
      • Stockholm, Sweden, 14186
        • Novartis Investigative Site
      • Uppsala, Sweden, 751 85
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
    • Taiwan ROC
      • Tainan, Taiwan ROC, Taiwan, 70421
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Antalya, Turkey, 07070
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Mecidiyekoy/Istanbul, Turkey, 34394
        • Novartis Investigative Site
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Novartis Investigative Site
    • California
      • Loma Linda, California, United States, 92354
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90033
        • Novartis Investigative Site
      • Sacramento, California, United States, 95817-1460
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
      • San Francisco, California, United States, 94115
        • Novartis Investigative Site
      • San Francisco, California, United States, 94143-0116
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novartis Investigative Site
      • Denver, Colorado, United States, 80210
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02215
        • Novartis Investigative Site
      • Burlington, Massachusetts, United States, 01805
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0331
        • Novartis Investigative Site
      • Detroit, Michigan, United States, 48202
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Novartis Investigative Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10467
        • Novartis Investigative Site
      • Buffalo, New York, United States, 14215
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Novartis Investigative Site
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, United States, 27157
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44106-5048
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43210
        • Novartis Investigative Site
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17105-8700
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212-3139
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76104
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030-2400
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Novartis Investigative Site
      • Milwaukee, Wisconsin, United States, 53226
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent obtained.
  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:

  1. Subject unable to tolerate oral medication at time of randomization.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Other Names:
  • Simulect, basiliximab, rATG, Thymoglobulin
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.
Other Names:
  • prednisone, methylprednisone, methylprednisolone, etc.
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Other Names:
  • Zortress, Certican, Neoral, Prograf
ACTIVE_COMPARATOR: MPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Other Names:
  • Simulect, basiliximab, rATG, Thymoglobulin
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.
Other Names:
  • prednisone, methylprednisone, methylprednisolone, etc.
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Other Names:
  • Myfortic, Cellcept, Neoral, Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Time Frame: Month 12 is Primary, Month 24 secondary
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
Month 12 is Primary, Month 24 secondary

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Time Frame: Month 12 and 24
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
Month 12 and 24
Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Time Frame: Month 12 and 24
Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
Month 12 and 24
Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Time Frame: Month 12 and 24
Incidence of failure on the composite endpoint of graft loss or death.
Month 12 and 24
Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
Time Frame: Month 12 and 24
Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)
Month 12 and 24
Incidence of eGFR < 50 mL/Min/1.73m2
Time Frame: Month 12 and 24
Incidence of eGFR < 50 mL/min/1.73m2
Month 12 and 24
Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Time Frame: Baseline (week 4), Month 12 and 24
Renal allograft function : mean estimated glomerular filtration rate, eGFR
Baseline (week 4), Month 12 and 24
Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Time Frame: Month 12 and 24
Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.
Month 12 and 24
Renal Function Assessed by Creatinine Lab Values
Time Frame: Month 12 and 24
Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.
Month 12 and 24
Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
Time Frame: Month 12 and 24
Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.
Month 12 and 24
Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Time Frame: Month 24
Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
Month 24
Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Time Frame: Month 24
Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
Month 24
Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Time Frame: Baseline, Month 12 and 24
Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
Baseline, Month 12 and 24
Incidence of Major Cardiovascular Events.
Time Frame: Month 24
Incidence of major cardiovascular events by Preferred Term
Month 24
Incidence of Malignancies.
Time Frame: Month 24
Incidence of malignancies.
Month 24
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
Time Frame: Month 12 and 24
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.
Month 12 and 24
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
Time Frame: Month 12 and 24

Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Month 12 and 24
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
Time Frame: Month 12 and 24

Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Month 12 and 24
Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
Time Frame: Month 12 and 24

Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Month 12 and 24
Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Time Frame: Month 12 and 24
Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup
Month 12 and 24
Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Time Frame: Month 12 and 24
Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
Month 12 and 24
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
Time Frame: Month 12 and 24
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
Month 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2013

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

January 17, 2018

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (ESTIMATE)

September 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydata request.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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