End Stage Renal Disease (ESRD)Phase 4TRANSFORMNCT01950819
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
A Phase 4 study testing Induction therapy, Corticosteroids and EVR+rCNI in people with End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), run by Novartis Pharmaceuticals at 184 sites in 42 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis
- What is being tested?
- Induction therapy, Corticosteroids and EVR+rCNI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,037 participants
- Where
- 184 sitesin 42 countries
- Study dates
- 3 Dec 2013to 17 Jan 2018
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Subject randomized within 24 hr of completion of transplant surgery.
- Recipient of a kidney with a cold ischemia time < 30 hours.
- 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.
Who cannot join
- Subject unable to tolerate oral medication at time of randomization.
- Use of other investigational drugs at the time of enrollment.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Multi-organ transplant recipient.
- Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
- 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.
Show all 18Show fewer
- Subject who is HIV-positive.
- 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.
- 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).
- Subject with a BMI greater than 35.
- Subject with severe systemic infections, current or within the two weeks prior to randomization.
- Subject requiring systemic anticoagulation.
- History of malignancy of any organ system.
- Subject with severe restrictive or obstructive pulmonary disorders.
- Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
- Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
- Pregnant or nursing (lactating) women.
- 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.
Trial locations and contacts
184 sites in 42 countries.
184 sites in 42 countries
United States40 sites
Novartis Investigative Site
Ann Arbor, Michigan, 48109-0331
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Baltimore, Maryland, 21201
Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Boston, Massachusetts, 02215
Novartis Investigative Site
Buffalo, New York, 14215
Novartis Investigative Site
Burlington, Massachusetts, 01805
Novartis Investigative Site
Chapel Hill, North Carolina, 27599
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Charlottesville, Virginia, 22908
Novartis Investigative Site
Chicago, Illinois, 60612
Novartis Investigative Site
Cleveland, Ohio, 44106-5048
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Dallas, Texas, 75246
Novartis Investigative Site
Denver, Colorado, 80210
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Fort Worth, Texas, 76104
Novartis Investigative Site
Harrisburg, Pennsylvania, 17105-8700
Novartis Investigative Site
Houston, Texas, 77030-2400
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Livingston, New Jersey, 07039
Novartis Investigative Site
Loma Linda, California, 92354
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Madison, Wisconsin, 53705
Novartis Investigative Site
Milwaukee, Wisconsin, 53226
Novartis Investigative Site
Nashville, Tennessee, 37212-3139
Novartis Investigative Site
Providence, Rhode Island, 02903
Novartis Investigative Site
Sacramento, California, 95817-1460
Novartis Investigative Site
Salt Lake City, Utah, 84132
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
San Francisco, California, 94115
Novartis Investigative Site
San Francisco, California, 94143-0116
Novartis Investigative Site
Seattle, Washington, 98195
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
The Bronx, New York, 10467
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
Germany12 sites
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 51109
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hannover Muenden, 34346
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Kaiserslautern, 67655
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
München, 81377
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Regensburg, Bavaria, 93053
Australia10 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Murdoch, Western Australia, 6150
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
Randwick, New South Wales, 2031
Novartis Investigative Site
Westmead, New South Wales, 2145
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Italy10 sites
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Roma, RM, 00144
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Torino, TO, 10126
Spain10 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Granada, Andalusia, 18014
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Valencia, Valencia, 46017
Novartis Investigative Site
Zaragoza, 50009
Argentina7 sites
Novartis Investigative Site
Buenos Aires, W3400ABH
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
Córdoba, X5016KEH
Novartis Investigative Site
Córdoba, X5016KET
Novartis Investigative Site
Corrientes, W3400
Novartis Investigative Site
San Martín, Buenos Aires, C1107BEA
Novartis Investigative Site
Santa Fe, S3000EPV
Netherlands6 sites
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Groningen
Novartis Investigative Site
Leiden, 2333 ZA
Novartis Investigative Site
Maastricht, AZ, 5800
Novartis Investigative Site
Nijmegen
Novartis Investigative Site
Utrecht, The Netherlands, 3508 GA
Russia6 sites
Novartis Investigative Site
Krasnodar, 350086
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Moscow, 129010
Novartis Investigative Site
Nizhny Novgorod, 603000
Novartis Investigative Site
Volzhskiy, 404120
Novartis Investigative Site
Yekaterinburg, 620109
France5 sites
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nice, Cedex1, 06001
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Tours, Indre Et Loire, 37044
Portugal5 sites
Novartis Investigative Site
Carnaxide, Lisbon District, 2790-134
Novartis Investigative Site
Coimbra, 3000 075
Novartis Investigative Site
Lisbon, 1069-166
Novartis Investigative Site
Lisbon, 1600190
Novartis Investigative Site
Porto, 4200 319
Belgium4 sites
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Edegem, Antwerpen, 2650
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Greece4 sites
Novartis Investigative Site
Athens, 106 76
Novartis Investigative Site
Athens, 11527
Novartis Investigative Site
Pátrai, 265 00
Novartis Investigative Site
Thessaloniki, GR, 546 42
India4 sites
Novartis Investigative Site
Bangalore, Karnataka, 560 055
Novartis Investigative Site
Mumbai, Maharashtra, 400 016
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110 017
Novartis Investigative Site
Vellore, Tamil Nadu, 632004
Poland4 sites
Novartis Investigative Site
Gdansk, 80 952
Novartis Investigative Site
Poznan, 60-355
Novartis Investigative Site
Poznan, 60-479
Novartis Investigative Site
Szczecin, Pomeranian Voivodeship, 70-111
Slovakia4 sites
Novartis Investigative Site
Banská Bystrica, 97517
Novartis Investigative Site
Bratislava, 833 05
Novartis Investigative Site
Košice, 04166
Novartis Investigative Site
Martin, 03659
Brazil3 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Croatia3 sites
Novartis Investigative Site
Rijeka, 51000
Novartis Investigative Site
Zagreb, 10000
Novartis Investigative Site
Zagreb, 1000
Japan3 sites
Novartis Investigative Site
Chiba, Chiba, 260-8712
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8650
Novartis Investigative Site
Toyoake, Aichi-ken, 470 1192
Lebanon3 sites
Novartis Investigative Site
El Achrafiyé, 166830
Novartis Investigative Site
Saida, 652
Novartis Investigative Site
Saida
Saudi Arabia3 sites
Novartis Investigative Site
Dammam, 15215
Novartis Investigative Site
Jeddah, 21499
Novartis Investigative Site
Riyadh, 11159
Serbia3 sites
Novartis Investigative Site
Belgrade, 11000
Novartis Investigative Site
Niš, 18000
Novartis Investigative Site
Novi Sad
South Korea3 sites
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, 03722
Sweden3 sites
Novartis Investigative Site
Gothenburg, SE-413 45
Novartis Investigative Site
Stockholm, 14186
Novartis Investigative Site
Uppsala, 751 85
Taiwan3 sites
Novartis Investigative Site
Taichung, 40705
Novartis Investigative Site
Tainan, Taiwan ROC, 70421
Novartis Investigative Site
Taipei, 10002
Turkey (Türkiye)3 sites
Novartis Investigative Site
Antalya, 07070
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Mecidiyekoy/Istanbul, 34394
Austria2 sites
Novartis Investigative Site
Innsbruck, Tyrol, 6020
Novartis Investigative Site
Linz, A-4010
Colombia2 sites
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Cali, Valle del Cauca Department
Czechia2 sites
Novartis Investigative Site
Brno, 656 91
Novartis Investigative Site
Prague, 140 00
Israel2 sites
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Tel Aviv, 64239
Malaysia2 sites
Novartis Investigative Site
Kuala Lumpur, 50589
Novartis Investigative Site
Selangor Darul Ehsan, 68100
Thailand2 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Ratchathewi, Bangkok, 10400
South Africa1 site
Novartis Investigative Site
Cape Town, Western Province, 7925
About this study
Official title: 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.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation
- Being tested
- Induction therapy, Corticosteroids, EVR+rCNI, MPA+sCNI
- Keywords
- kidney failure, dialysis, renal failure, transplantation
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction therapyBiological
Also called Simulect, basiliximab, rATG, Thymoglobulin
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
CorticosteroidsDrug
Also called prednisone, methylprednisone, methylprednisolone, etc.
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+rCNIDrug
Also called Zortress, Certican, Neoral, Prograf
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+sCNIDrug
Also called Myfortic, Cellcept, Neoral, Prograf
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
| Study group | Role | What they receive |
|---|---|---|
| EVR+rCNI | Experimental | Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus) Receives: Biological: Induction therapy; Drug: Corticosteroids; Drug: EVR+rCNI |
| MPA+sCNI | Active comparator | Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus). Receives: Biological: Induction therapy; Drug: Corticosteroids; Drug: MPA+sCNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
Measured: Month 12 is Primary, Month 24 secondary
Secondary outcomes (21)
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
Measured: Month 12 and 24
Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
Measured: Month 12 and 24
Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Incidence of failure on the composite endpoint of graft loss or death.
Measured: Month 12 and 24
Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
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)
Measured: Month 12 and 24
Incidence of eGFR < 50 mL/Min/1.73m2
Incidence of eGFR < 50 mL/min/1.73m2
Measured: Month 12 and 24
Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Renal allograft function : mean estimated glomerular filtration rate, eGFR
Measured: Baseline (week 4), Month 12 and 24
Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.
Measured: Month 12 and 24
Renal Function Assessed by Creatinine Lab Values
Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.
Measured: Month 12 and 24
Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
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.
Measured: Month 12 and 24
Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
Measured: Month 24
Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
Measured: Month 24
Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
Measured: Baseline, Month 12 and 24
Incidence of Major Cardiovascular Events.
Incidence of major cardiovascular events by Preferred Term
Measured: Month 24
Incidence of Malignancies.
Incidence of malignancies.
Measured: 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.
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.
Measured: Month 12 and 24
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
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)
Measured: Month 12 and 24
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
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)
Measured: Month 12 and 24
Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
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)
Measured: Month 12 and 24
Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup
Measured: Month 12 and 24
Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
Measured: 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
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
Measured: Month 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start3 Dec 2013
- Primary completion1 Feb 2017
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label study
- Masking
- None (open label)
- Enrolment
- 2,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950819
- Sponsor's protocol ID
- CRAD001A2433
- Other IDs
- 2013-000322-66
- Acronym
- TRANSFORM
- Status last verified
- Jan 2019
- First submitted
- 20 Aug 2013
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 34620664Watarai 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.
PubMed 34216395Citterio 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.
PubMed 32633157Berger 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.
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