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

Primary Purpose

End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Induction therapy

Corticosteroids

EVR+rCNI

MPA+sCNI

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD) focused on measuring kidney failure, dialysis, renal failure, transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EVR+rCNI

MPA+sCNI

Arm Description

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Incidence of Failure on the Composite Endpoint of Graft Loss or Death.

Incidence of failure on the composite endpoint of graft loss or death.

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)

Incidence of eGFR < 50 mL/Min/1.73m2

Incidence of eGFR < 50 mL/min/1.73m2

Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR

Renal allograft function : mean estimated glomerular filtration rate, eGFR

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.

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.

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.

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.

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.

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.

Incidence of Major Cardiovascular Events.

Incidence of major cardiovascular events by Preferred Term

Incidence of Malignancies.

Incidence of malignancies.

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.

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)

Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)

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)

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

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

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

Full Information

NCT ID

NCT01950819

First Posted

August 20, 2013

Last Updated

January 9, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01950819

Brief Title

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

Acronym

TRANSFORM

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 3, 2013 (Actual)

Primary Completion Date

February 1, 2017 (Actual)

Study Completion Date

January 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation

Keywords

kidney failure, dialysis, renal failure, transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Open-label study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2037 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVR+rCNI

Arm Type

Experimental

Arm Description

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

Arm Title

MPA+sCNI

Arm Type

Active Comparator

Arm Description

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Intervention Type

Biological

Intervention Name(s)

Induction therapy

Other Intervention Name(s)

Simulect, basiliximab, rATG, Thymoglobulin

Intervention Description

All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.

Intervention Type

Drug

Intervention Name(s)

Corticosteroids

Other Intervention Name(s)

prednisone, methylprednisone, methylprednisolone, etc.

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

EVR+rCNI

Other Intervention Name(s)

Zortress, Certican, Neoral, Prograf

Intervention Description

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

Intervention Type

Drug

Intervention Name(s)

MPA+sCNI

Other Intervention Name(s)

Myfortic, Cellcept, Neoral, Prograf

Intervention Description

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Primary Outcome Measure Information:

Title

Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.

Description

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

Secondary Outcome Measure Information:

Title

Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death

Description

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death

Time Frame

Month 12 and 24

Title

Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2

Description

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

Title

Incidence of Failure on the Composite Endpoint of Graft Loss or Death.

Description

Incidence of failure on the composite endpoint of graft loss or death.

Time Frame

Month 12 and 24

Title

Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection

Description

Time Frame

Month 12 and 24

Title

Incidence of eGFR < 50 mL/Min/1.73m2

Description

Incidence of eGFR < 50 mL/min/1.73m2

Time Frame

Month 12 and 24

Title

Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR

Description

Renal allograft function : mean estimated glomerular filtration rate, eGFR

Time Frame

Baseline (week 4), Month 12 and 24

Title

Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.

Description

Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.

Time Frame

Month 12 and 24

Title

Renal Function Assessed by Creatinine Lab Values

Description

Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.

Time Frame

Month 12 and 24

Title

Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported

Description

Time Frame

Month 12 and 24

Title

Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.

Description

Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.

Time Frame

Month 24

Title

Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.

Description

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

Title

Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.

Description

Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.

Time Frame

Baseline, Month 12 and 24

Title

Incidence of Major Cardiovascular Events.

Description

Incidence of major cardiovascular events by Preferred Term

Time Frame

Month 24

Title

Incidence of Malignancies.

Description

Incidence of malignancies.

Time Frame

Month 24

Title

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.

Description

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

Title

Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)

Description

Time Frame

Month 12 and 24

Title

Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)

Description

Time Frame

Month 12 and 24

Title

Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections

Description

Time Frame

Month 12 and 24

Title

Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup

Description

Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup

Time Frame

Month 12 and 24

Title

Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2

Description

Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2

Time Frame

Month 12 and 24

Title

Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Novartis Investigative Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817-1460

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-0116

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0331

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Novartis Investigative Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Novartis Investigative Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5048

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Novartis Investigative Site

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17105-8700

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-3139

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-2400

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Martin

State/Province

Buenos Aires

ZIP/Postal Code

C1107BEA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

W3400ABH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KET

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

W3400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000EPV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novartis Investigative Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

04038-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sofia

State/Province

BGR

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Novartis Investigative Site

City

Cali

State/Province

Valle Del Cauca

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

Country

Colombia

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

1000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Mansoura

Country

Egypt

Facility Name

Novartis Investigative Site

City

Nice

State/Province

Cedex1

ZIP/Postal Code

06001

Country

France

Facility Name

Novartis Investigative Site

City

Tours Cedex 9

State/Province

Indre Et Loire

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 15

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover Muenden

ZIP/Postal Code

34346

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 42

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 017

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 055

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 016

Country

India

Facility Name

Novartis Investigative Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632004

Country

India

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyoake city

State/Province

Aichi

ZIP/Postal Code

470 1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba-city

State/Province

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Kuwait

Country

Kuwait

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Saida

ZIP/Postal Code

652

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Saida

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

50589

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Selangor Darul Ehsan

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44610

Country

Mexico

Facility Name

Novartis Investigative Site

City

Maastricht

State/Province

ZIP/Postal Code

5800

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

State/Province

The Netherlands

ZIP/Postal Code

3508 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Novartis Investigative Site

City

Szczecin

State/Province

Pomorskie

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-479

Country

Poland

Facility Name

Novartis Investigative Site

City

Carnaxide

State/Province

Lisboa

ZIP/Postal Code

2790-134

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000 075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1600190

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisbon

ZIP/Postal Code

1069-166

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Krasnodar

ZIP/Postal Code

350086

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

129010

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhnii Novgorod

ZIP/Postal Code

603000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volzhskiy

ZIP/Postal Code

404120

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Dammam

ZIP/Postal Code

15215

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Jeddah

ZIP/Postal Code

21499

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Riyadh

ZIP/Postal Code

11159

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Novi Sad

Country

Serbia

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banská Bystrica

ZIP/Postal Code

97517

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04166

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

03659

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Cape Town

State/Province

Western Province

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18014

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46017

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Tainan

State/Province

Taiwan ROC

ZIP/Postal Code

70421

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mecidiyekoy/Istanbul

ZIP/Postal Code

34394

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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

Citations:

PubMed Identifier

34620664

Citation

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.

Results Reference

derived

PubMed Identifier

34216395

Citation

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.

Results Reference

derived

PubMed Identifier

32633157

Citation

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.

Results Reference

derived

PubMed Identifier

31152476

Citation

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.

Results Reference

derived

PubMed Identifier

29752413

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial