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CompletedNCT00658320Updated Jun 21, 2013Results posted

Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

A Phase 3 interventional study of Everolimus and Mycophenolate mofetil (MMF) in Kidney Transplantation, sponsored by Novartis. Completed at 1 site in Japan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Novartis · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard dose cyclosporine and corticosteroids in de novo renal transplant recipients.

Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was designed to evaluate the long-term safety and efficacy comparing concentration-controlled everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant recipients. Beyond 24 months after renal transplantation, the study was designed to provide everolimus treatment for patients in everolimus group until everolimus is approved and marketed in Japan.

02

Conditions studied

  • Kidney Transplantation

Keywords

  • Renal transplantation
  • everolimus
  • mycophenolate mofetil
  • cyclosporine
  • corticosteroid
  • basiliximab
  • Banff diagnosis
  • Acute rejection
  • Therapeutic drug monitoring (TDM)
  • de novo renal transplant recipient
03

In context

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Core Study Inclusion Criteria:

  • Male or female de novo renal transplant recipients between 18 and 65 years of age
  • Patients who are receiving a primary cadaveric donor or non-human leukocyte antigen (non-HLA) identical living donor kidney transplant
  • Patients who have given written informed consent to participate in the study
  • Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Core Study Exclusion Criteria:

  • Patients with no evidence of graft function within 24 hours of transplantation are excluded
  • Recipients of dual kidney transplants
  • Patients who are recipients of multiple solid organ or tissue transplants, or have previously received an organ or tissue transplant.
  • Recipients of kidneys from HLA-identical living related donors
  • Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. Although Panel Reactive Antibodies (PRA) test is not mandatory, patients whose most recent anti-HLA Class I PRA >20% By a CDC-(Complement dependent cytotoxicity) based assay or >50% by a Flow Cytometry or ELISA (Enzyme linked immunosorbent assay) -based assay
  • Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within two weeks prior to randomization.
  • Recipients of organs from donors who test positive for Hepatitis B surface antigen, HCV or HIV are excluded
  • Donor organ with a cold ischemia time >24 hours
  • Donor age greater than 65 years
  • Patients with platelet count \<100,000/mm at baseline before transplantation
  • Patients with an absolute neutrophil count of \< 1,500/mm³ or white blood cell count of \< 4,500/mm³ at baseline before transplantation
  • Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
  • Patients who have an abnormal liver profile such as alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin >3 times the upper limit of normal (ULN)
  • Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
  • Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450
  • Patients who are unable to take oral medication at time of randomization
  • Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
  • Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions
  • Patients with clinically significant systemic infection at time of transplant or within two weeks prior to transplant
  • Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
  • Patients who have cardiac failure at time of screening (resting dyspnea, with Grade ≥ 3 according to Old New York Heart Association Classification (Appendix 7) or any severe cardiac disease as determined by the investigator
  • Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication
  • Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks prior to randomization which would interfere with the objectives of the study
  • Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed)
  • Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Extension Study Inclusion Criteria:

  • Patients who completed Month 12 visit in core study (including patients who had discontinued study medication)
  • Patients who had given written informed consent to participate in this extension study

Extension Study Exclusion Criteria:

  • Women of childbearing potential who were planning to become pregnant, who were unwilling to use two or more effective means of contraception, including abstinence judged by the investigator, surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and barrier methods (male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Everolimus + Reduced dose of cyclosporine

    An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.

    Drug: Everolimus · Drug: Basiliximab · Drug: Cyclosporine A · Drug: Corticosteroid

  • Active comparator
    Mycophenolate mofetil (MMF) + Standard dose of cyclosporine

    Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.

    Drug: Mycophenolate mofetil (MMF) · Drug: Basiliximab · Drug: Cyclosporine A · Drug: Corticosteroid

Interventions

  • DrugEverolimus

    0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.

    Also known as: Certican

  • DrugMycophenolate mofetil (MMF)

    The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.

    Also known as: MMF

  • DrugBasiliximab

    Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice

  • DrugCyclosporine A

    The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.

    Also known as: Neoral®

  • DrugCorticosteroid

    Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study

06

What researchers measure

Primary outcomes

  1. Core Study: Number of Patients With Composite Efficacy Endpoint

    The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss. For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur.

    Time frame: 12 months

  2. Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula

    Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula: GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1 Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up

    Time frame: Month 24

  3. Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula

    Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula: GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1

    Time frame: Month 48

Secondary outcomes

  1. Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up

    The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss. A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window.

    Time frame: 12 months

  2. Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula

    Modification of Diet in Renal Disease (MDRD) formula is: Calculated GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1

    Time frame: Month 12

  3. Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)

    Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant. Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24. A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff '97 criteria. Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy.

    Time frame: 24 Months

  4. Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula

    The Nankivell formula was used to calculate GFR at Month 24: GFR\[mL/min\]=6.7/C + W/4 - UREA/2 - 100/H\^2 + 35 (25 for females) W= body weight \[kg\] H= height \[m\] C= serum creatinine \[mmol/L\] UREA= serum urea \[mmol\\L\]

    Time frame: Month 24, Month 48

  5. Extension Study: Number of Participants With Adverse Events and Serious Adverse Events

    Additional information about Adverse Events can be found in the Adverse Event Section.

    Time frame: 24 Months

  6. Extension Study: Everolimus Trough Levels

    Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.

    Time frame: Month 24, Month 48

  7. Extension Study: Cyclosporine Trough Levels

    Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.

    Time frame: Month 24, Month 48

07

Results

Posted Sep 14, 2011

Participant flow

Core Study: 12 Months
Participant flow — Core Study: 12 Months
MilestoneEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Started6161
Completed5658
Not completed53
Withdrew: Subject withdrew consent53
Extension Study: Month 12 to Month 24
Participant flow — Extension Study: Month 12 to Month 24
MilestoneEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Started5357
Extension itt: received study drug5050
Completed4750
Not completed67
Withdrew: Subject withdrew consent30
Withdrew: Did not receive study drug in extension37
Extension Study: After Month 24
Participant flow — Extension Study: After Month 24
MilestoneEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Started440
Completed420
Not completed20
Withdrew: Subject withdrew consent20

Outcome measures

PrimaryCore Study: Number of Patients With Composite Efficacy Endpoint

The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss. For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur.

Time frame:
12 months
Reported as:
Number · Participants
Core Study: Number of Patients With Composite Efficacy Endpoint
ParticipantsEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Composite Efficacy Endpoint77
Treated BPAR35
Graft Loss00
Death00
Loss to follow up (see caveats)42
SecondaryCore Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up

The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss. A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window.

Time frame:
12 months
Reported as:
Number · Participants
Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up
ParticipantsEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up53
SecondaryCore Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula

Modification of Diet in Renal Disease (MDRD) formula is: Calculated GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1

Time frame:
Month 12
Reported as:
Median · mL/min/1.73m^2
Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula
mL/min/1.73m^2Everolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula58.00 ± 18.99355.25 ± 15.227
PrimaryExtension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula

Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula: GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1 Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up

Time frame:
Month 24
Reported as:
Median · mL/min/1.73m^2
Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula
mL/min/1.73m^2Everolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula58.90 (14.4 to 118.9)54.95 (28.3 to 92.7)
SecondaryExtension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)

Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant. Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24. A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff '97 criteria. Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy.

Time frame:
24 Months
Reported as:
Number · Participants
Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)
ParticipantsEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Combined Efficacy Endpoint45
Treated BPAR35
Graft Loss00
Death00
Loss to follow-up10
SecondaryExtension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula

The Nankivell formula was used to calculate GFR at Month 24: GFR\[mL/min\]=6.7/C + W/4 - UREA/2 - 100/H\^2 + 35 (25 for females) W= body weight \[kg\] H= height \[m\] C= serum creatinine \[mmol/L\] UREA= serum urea \[mmol\\L\]

Time frame:
Month 24, Month 48
Reported as:
Mean · mL/min
Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula
mL/minEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Month 2463.49 ± 20.47959.24 ± 13.840
Month 48 (9,0)60.16 ± 9.892NA ± NA
SecondaryExtension Study: Number of Participants With Adverse Events and Serious Adverse Events

Additional information about Adverse Events can be found in the Adverse Event Section.

Time frame:
24 Months
Reported as:
Number · Participants
Extension Study: Number of Participants With Adverse Events and Serious Adverse Events
ParticipantsEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Adverse Events5050
Serious Adverse Events3030
SecondaryExtension Study: Everolimus Trough Levels

Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.

Time frame:
Month 24, Month 48
Reported as:
Mean · ng/mL
Extension Study: Everolimus Trough Levels
ng/mLEverolimus + Reduced Dose of Cyclosporine
Month 245.258 ± 1.1170
Month 48 (n=8)4.408 ± 0.5986
SecondaryExtension Study: Cyclosporine Trough Levels

Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.

Time frame:
Month 24, Month 48
Reported as:
Mean · ng/mL
Extension Study: Cyclosporine Trough Levels
ng/mLEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Month 2454.1 ± 39.07105.5 ± 44.16
Month 48 (n=7,0)34.2 ± 37.94NA ± NA
PrimaryExtension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula

Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula: GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1

Time frame:
Month 48
Reported as:
Median · mL/min/1.73m^2
Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula
mL/min/1.73m^2Everolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula59.80 (36.8 to 72.0)—

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Everolimus + Reduced Dose of Cyclosporine—37/61 (60.7%)61/61 (100%)
Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine—37/61 (60.7%)61/61 (100%)
Most frequent serious events
Showing 10 of 78
Most frequent serious events
EventEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
Cytomegalovirus infectionInfections and infestations1/6111/61
Cytomegalovirus test positiveInvestigations2/6110/61
Blood creatinine increasedInvestigations5/616/61
ProteinuriaRenal and urinary disorders5/612/61
GastroenteritisInfections and infestations2/614/61
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders4/611/61
PyrexiaGeneral disorders3/612/61
CataractEye disorders2/610/61
Inguinal herniaGastrointestinal disorders2/610/61
Herpes zosterInfections and infestations1/612/61
Most frequent other events
Showing 10 of 77
Most frequent other events
EventEverolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
NasopharyngitisInfections and infestations37/6138/61
HyperlipidaemiaMetabolism and nutrition disorders30/6120/61
ConstipationGastrointestinal disorders19/6127/61
DiarrhoeaGastrointestinal disorders22/6115/61
AcneSkin and subcutaneous tissue disorders18/6122/61
HypertensionVascular disorders21/6118/61
PyrexiaGeneral disorders14/6117/61
InsomniaPsychiatric disorders17/619/61
Iron deficiency anaemiaBlood and lymphatic system disorders14/6116/61
Cytomegalovirus test positiveInvestigations3/6116/61

Baseline characteristics

Baseline Measures are based on the data obtained in the Core Study.

Age Continuous
Age Continuous(years)Everolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of CyclosporineTotal
Mean42.5 ± 14.1338.6 ± 11.3640.5 ± 12.92
Sex: Female, Male
Sex: Female, Male(Participants)Everolimus + Reduced Dose of CyclosporineMycophenolate Mofetil (MMF) + Standard Dose of CyclosporineTotal
Female152439
Male463783
08

Study locations

1 site
  • Novartis Pharma K.K., Japan
    Tokyo, 106-8618, Japan
09

References and documents

Publications

  • Takahashi K, Uchida K, Yoshimura N, Takahara S, Teraoka S, Teshima R, Cornu-Artis C, Kobayashi E. Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results. Transplant Res. 2013 Jul 16;2(1):14. doi: 10.1186/2047-1440-2-14. PubMed 23866828 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00658320
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Apr 15, 2008
Start date
Feb 2008
Primary completion
Aug 2010
Completion
May 2012
Results posted
Sep 14, 2011
Last update
Jun 21, 2013

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

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