CompletedNCT00377962NOCTETUpdated Jul 30, 2020Results posted

Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

A Phase 4 interventional study of Everolimus and Mycophenolic acid (MPA)/azathioprine (AZA) in Disorder Related to Cardiac Transplantation, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 282
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.

Conditions studied

Disorder Related to Cardiac Transplantation

Keywords

thoracic transplant recipients
everolimus
immunosuppressants

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

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

Who can participate

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

Inclusion criteria

Patients who have undergone a heart or lung transplantation more than 12 months ago.
Patients receiving Neoral® or Prograf®.
Patients with a measured or calculated glomerular filtration rate (GFR) > 20 and \< 70 mL/min/1.73m\^2. For patients with a GFR > 60 and \< 70 mL/min/1.73m\^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is > 10% above the GFR level at the time of inclusion.
Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.

Exclusion criteria

Exclusion criteria:

Patients who are recipients of multiple organ transplants.
Patients with measured GFR \< 20 mL/min/1.73m\^2 or > 70 mL/min/1.73m\^2.
Patients with a treated acute rejection episode within the last 3 months.
Patients with a platelet count of \< 50,000/mm\^3 or with a white blood cell count of ≤ 2,500/mm\^3 or with a hemoglobin value \< 8 g/dL.
Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
Patients who have received an investigational drug within 4 weeks.
Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
Patients with a known hypersensitivity to drugs similar to everolimus.
Symptoms of significant mental illness which, in the opinion of the investigator, may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
Inability to cooperate or communicate with the investigator.
Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 282 participants (actual)

Study arms

Experimental
Everolimus + CNI reduction
Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level \< 75 ng/mL or a tacrolimus trough level \< 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice.
Drug: Everolimus · Drug: Calcineurin inhibitors (CNI) · Drug: Steroids
Active comparator
Control
CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
Drug: Mycophenolic acid (MPA)/azathioprine (AZA) · Drug: Calcineurin inhibitors (CNI) · Drug: Steroids

Interventions

DrugEverolimus
0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
Also known as: Certican
DrugMycophenolic acid (MPA)/azathioprine (AZA)
In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
Also known as: Neoral®/Prograf®
DrugCalcineurin inhibitors (CNI)
Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
DrugSteroids
Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

What researchers measure

Primary outcomes

Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
Time frame: Baseline to Month 12

Secondary outcomes

Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
Time frame: Baseline to end of study (Month 24)
Change in Serum Creatinine From Baseline to End of Study (Month 24)
Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.
Time frame: Baseline to end of study (Month 24)
Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)
Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart \& Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.
Time frame: Month 12 to end of study (Month 24)
Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)
Number of patients not alive and number of patients with loss of their graft.
Time frame: Month 12 to end of study (Month 24)
Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.
Time frame: Baseline to end of study (Month 24)
Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.
Time frame: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.
Time frame: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.
Time frame: Baseline to end of study (Month 24)
Mean Days of Hospitalization From Baseline to End of Study (Month 24)
Time frame: Baseline to end of study (Month 24)
Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)

Results

Posted Apr 18, 2011

Participant flow

This was a 12-month study in maintenance heart and lung transplant patients with a follow-up period of an additional 12 months. Results to 24 months are presented. Patients were randomized to continue their current calcineurin inhibitors (CNI) based regimen or to start everolimus with reduction of CNI blood levels.

Core Study: 0-12 Months

Participant flow — Core Study: 0-12 Months
Milestone	Everolimus + CNI Reduction	Control
Started	140	142
Completed	112	133
Not completed	28	9
Withdrew: Adverse event	18	2
Withdrew: Death	3	0
Withdrew: Withdrew consent	5	2
Withdrew: Administrative reason	1	1
Withdrew: Unspecified reasons	1	4

Extension Study: 12-24 Months

Participant flow — Extension Study: 12-24 Months
Milestone	Everolimus + CNI Reduction	Control
Started	108	127
Completed	98	123
Not completed	10	4
Withdrew: Death	1	1
Withdrew: Adverse event	8	0
Withdrew: Abnormal laboratory value	1	0
Withdrew: Unspecified reason	0	3

Outcome measures

PrimaryChange in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12

Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.

Time frame:: Baseline to Month 12
Reported as:: Mean · mL/min

Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
mL/min	Everolimus + CNI Reduction	Control
Baseline	48.6 ± 15.1	48.0 ± 13.2
Month 12	53.2 ± 15.7	47.5 ± 16.1
Change from Baseline	4.6 ± 10.4	-0.5 ± 9.0

SecondaryChange in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · mL/min

Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)
mL/min	Everolimus + CNI Reduction	Control
Month 0	49.3 ± 14.7	49.1 ± 13.0
Month 24	52.5 ± 16.4	46.8 ± 15.2
Change	3.2 ± 12.3	-2.4 ± 9.0

SecondaryChange in Serum Creatinine From Baseline to End of Study (Month 24)

Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · μmol/L

Change in Serum Creatinine From Baseline to End of Study (Month 24)
μmol/L	Everolimus + CNI Reduction	Control
Month 0	126 ± 30	129 ± 29
Month 24	126 ± 64	132 ± 37
Change	0 ± 53	3 ± 23

SecondaryNumber of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)

Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart \& Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.

Time frame:: Month 12 to end of study (Month 24)
Reported as:: Number · Participants

Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)
Participants	Everolimus + CNI Reduction	Control
Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)	6	5

SecondaryNumber of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)

Number of patients not alive and number of patients with loss of their graft.

Time frame:: Month 12 to end of study (Month 24)
Reported as:: Number · Participants

Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)
Participants	Everolimus + CNI Reduction	Control
Death	3	0
Graft Loss	0	0

SecondaryNumber of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)

Time frame:: Month 12 to end of study (Month 24)
Reported as:: Number · Participants

Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)
Participants	Everolimus + CNI Reduction	Control
Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)	0	2

SecondaryChange in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup

Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · Liters

Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Liters	Everolimus + CNI Reduction	Control
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup	-0.2 ± 0.2	-0.1 ± 0.2

SecondaryChange in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup

Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · Liters

Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Liters	Everolimus + CNI Reduction	Control
Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup	-0.2 ± 0.3	-0.1 ± 0.4

SecondaryChange in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup

Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · cm

Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
cm	Everolimus + CNI Reduction	Control
LVEDD	-0.1 ± 0.8	-0.0 ± 0.4
LVESD	0.1 ± 0.7	0.1 ± 0.6
IVSTd	-0.4 ± 2.4	-0.1 ± 1.2
PWTd	-0.5 ± 2.1	-0.1 ± 1.1

SecondaryChange in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup

Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · percentage

Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
percentage	Everolimus + CNI Reduction	Control
EF	-0.6 ± 8.5	0.1 ± 7.9
FF	0 ± 1	0 ± 1

SecondaryMean Days of Hospitalization From Baseline to End of Study (Month 24)

Time frame:: Baseline to end of study (Month 24)
Reported as:: Mean · Days

Mean Days of Hospitalization From Baseline to End of Study (Month 24)
Days	Everolimus + CNI Reduction	Control
Mean Days of Hospitalization From Baseline to End of Study (Month 24)	8.5 ± 7.4	16.2 ± 19.3

SecondaryNumber of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)

Time frame:: Month 12 to end of study (Month 24)
Reported as:: Number · Participants

Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)
Participants	Everolimus + CNI Reduction	Control
Total discontinued due to AE(s)	8	0
Pulmonary embolism	2	0
Skin problems	1	0
Hypercholesterolemia	1	0
Stroke	1	0
Muscular pain	1	0
Diarrhea	1	0
Edema	1	0

Adverse events

Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control: 12 Month Heart	—	23/96 (24%)	48/96 (50%)
Everolimus + CNI Reduction: 12 Month Heart	—	40/94 (42.6%)	75/94 (79.8%)
Control: 12 Month Lung	—	17/46 (37%)	33/46 (71.7%)
Everolimus+CNI Reduction: 12 Month Lung	—	25/46 (54.3%)	42/46 (91.3%)
Control: 24 Month Heart	—	31/86 (36%)	33/86 (38.4%)
Everolimus + CNI Reduction: 24 Month Heart	—	25/69 (36.2%)	29/69 (42%)
Control: 24 Month Lung	—	21/41 (51.2%)	21/41 (51.2%)
Everolimus + CNI Reduction: 24 Month Lung	—	16/39 (41%)	27/39 (69.2%)

Most frequent serious events

Showing 10 of 162

Most frequent serious events
Event	Control: 12 Month Heart	Everolimus + CNI Reduction: 12 Month Heart	Control: 12 Month Lung	Everolimus+CNI Reduction: 12 Month Lung	Control: 24 Month Heart	Everolimus + CNI Reduction: 24 Month Heart	Control: 24 Month Lung	Everolimus + CNI Reduction: 24 Month Lung
Pneumonia NOSInfections and infestations	3/96	7/94	3/46	6/46	2/86	0/69	7/41	5/39
Obliterative bronchiolitisRespiratory, thoracic and mediastinal disorders	0/96	0/94	1/46	2/46	0/86	0/69	6/41	1/39
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	3/96	1/94	1/46	1/46	0/86	0/69	1/41	2/39
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/96	0/94	0/46	0/46	1/86	1/69	2/41	0/39
Excessive bronchial secretionRespiratory, thoracic and mediastinal disorders	0/96	0/94	0/46	0/46	0/86	0/69	2/41	0/39
Bronchitis acute NOSInfections and infestations	0/96	0/94	2/46	0/46	0/86	0/69	1/41	1/39
Pseudomonas aeruginosa infection NOSInfections and infestations	0/96	0/94	0/46	2/46	0/86	0/69	0/41	0/39
Pulmonary embolismVascular disorders	1/96	1/94	2/46	2/46	1/86	2/69	1/41	1/39
Oedema NOSCardiac disorders	0/96	3/94	0/46	0/46	1/86	1/69	0/41	0/39
PyrexiaGeneral disorders	1/96	3/94	0/46	0/46	0/86	0/69	0/41	0/39

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Control: 12 Month Heart	Everolimus + CNI Reduction: 12 Month Heart	Control: 12 Month Lung	Everolimus+CNI Reduction: 12 Month Lung	Control: 24 Month Heart	Everolimus + CNI Reduction: 24 Month Heart	Control: 24 Month Lung	Everolimus + CNI Reduction: 24 Month Lung
Oedema NOSCardiac disorders	10/96	24/94	3/46	14/46	9/86	4/69	2/41	5/39
NasopharyngitisInfections and infestations	15/96	18/94	12/46	11/46	12/86	7/69	7/41	8/39
Upper respiratory tract infection NOSInfections and infestations	1/96	2/94	6/46	9/46	2/86	2/69	4/41	6/39
Leucopenia NOSBlood and lymphatic system disorders	0/96	8/94	0/46	8/46	1/86	1/69	0/41	1/39
Diarrhoea NOSGastrointestinal disorders	4/96	15/94	3/46	7/46	0/86	4/69	1/41	3/39
HypercholesterolaemiaMetabolism and nutrition disorders	4/96	0/94	3/46	6/46	1/86	2/69	0/41	2/39
Hypertension NOSVascular disorders	5/96	4/94	4/46	6/46	0/86	3/69	2/41	3/39
Acne NOSSkin and subcutaneous tissue disorders	0/96	11/94	0/46	1/46	0/86	0/69	0/41	1/39
Mouth ulcerationGastrointestinal disorders	0/96	1/94	0/46	5/46	0/86	0/69	0/41	0/39
Pneumonia NOSInfections and infestations	5/96	3/94	2/46	5/46	1/86	0/69	0/41	3/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Everolimus + CNI Reduction	Control	Total
Mean	59.2 ± 9.5	56.4 ± 10.7	57.8 ± 9.96

Sex: Female, Male
Sex: Female, Male(Participants)	Everolimus + CNI Reduction	Control	Total
Female	37	40	77
Male	103	102	205

Study locations

6 sites

Novartis Investigative Site
Arhus, DK-8200, Denmark
Novartis Investigative Site
Copenhagen, 2100, Denmark
Novartis Investigative Site
Oslo, Norway
Novartis Investigative Site
Goteborg, 413 45, Sweden
Novartis Investigative Site
Linkoping, 581 85, Sweden
Novartis Investigative Site
Lund, 22185, Sweden

References and documents

Publications

Norum HM, Michelsen AE, Lekva T, Arora S, Otterdal K, Olsen MB, Kong XY, Gude E, Andreassen AK, Solbu D, Karason K, Dellgren G, Gullestad L, Aukrust P, Ueland T. Circulating delta-like Notch ligand 1 is correlated with cardiac allograft vasculopathy and suppressed in heart transplant recipients on everolimus-based immunosuppression. Am J Transplant. 2019 Apr;19(4):1050-1060. doi: 10.1111/ajt.15141. Epub 2018 Nov 5. PubMed 30312541 ↗
Arora S, Erikstad I, Ueland T, Sigurdardottir V, Ekmehag B, Jansson K, Eiskjaer H, Botker HE, Mortensen SA, Saunamaki K, Gude E, Ragnarsson A, Solbu D, Aukrust P, Gullestad L. Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial. Am J Transplant. 2012 Oct;12(10):2700-9. doi: 10.1111/j.1600-6143.2012.04234.x. Epub 2012 Sep 7. PubMed 22958738 ↗
Arora S, Gude E, Sigurdardottir V, Mortensen SA, Eiskjaer H, Riise G, Mared L, Bjortuft O, Ekmehag B, Jansson K, Simonsen S, Aukrust P, Solbu D, Iversen M, Gullestad L. Improvement in renal function after everolimus introduction and calcineurin inhibitor reduction in maintenance thoracic transplant recipients: the significance of baseline glomerular filtration rate. J Heart Lung Transplant. 2012 Mar;31(3):259-65. doi: 10.1016/j.healun.2011.12.010. PubMed 22333403 ↗

Individual participant data

Plan to share: 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.clinicalstudydatarequest.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00377962
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Sep 19, 2006
Start date: Dec 2005
Primary completion: Feb 2010
Completion: Feb 2010
Results posted: Apr 18, 2011
Last update: Jul 30, 2020

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

View the source record on ClinicalTrials.gov ↗

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