Trial Outcomes & Findings for Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients (NCT NCT01404325)

Last Updated: 2019-03-14

Results Overview

Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

130 participants

Primary outcome timeframe

Month 12

Results posted on

2019-03-14

Participant Flow

232 patients who were de novo lung transplant recipients were planned for enrolling into the study. A total of 130 patients were actually randomized with 67 patients randomized to the quadruple low-level treatment arm and 63 patients randomized to the center-specific triple treatment arm.

Participant milestones

Participant milestones
Measure	Quadruple Low Level IS Regimen quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen centre specific CNI-based triple drug immunosuppression (IS)
Overall Study STARTED	67	63
Overall Study COMPLETED	63	61
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Quadruple Low Level IS Regimen quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen centre specific CNI-based triple drug immunosuppression (IS)
Overall Study Lost to Follow-up	1	0
Overall Study Death	2	0
Overall Study Graft loss/Retransplantation	1	0
Overall Study non-specified reason	0	2

Baseline Characteristics

Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)	Total n=130 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 9.5 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	54.0 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set multiple imputation (FAS MI) consisted of all patients as randomized that received at least 1 dose of study drug \& had a valid baseline assessment of the primary efficacy variable. Missing values was dealt with by multiple imputation (MI)

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months	64.5 mL/min 95% Confidence Interval 16.3 • Interval 59.4 to 69.6	54.6 mL/min 95% Confidence Interval 14.3 • Interval 49.5 to 59.7

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Population: Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.

Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9 and 12. The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 Month 12	68.3 mL/min Standard Deviation 16.3	61.2 mL/min Standard Deviation 14.3
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 Month 1	73.5 mL/min Standard Deviation 13.9	67.1 mL/min Standard Deviation 12.4
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 Month 3	70.4 mL/min Standard Deviation 13.3	64.3 mL/min Standard Deviation 12.7
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 Month 6	69.2 mL/min Standard Deviation 15.5	63.1 mL/min Standard Deviation 15.0
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 Month 9	69.0 mL/min Standard Deviation 16.3	62.3 mL/min Standard Deviation 14.8

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Calculated Glomerular Filtration Rate (cGFR) according to Cystatin C-based Hoek's formula at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 Month 1	68.5 mL/min Standard Deviation 14.6	61.8 mL/min Standard Deviation 12.8
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 Month 3	65.7 mL/min Standard Deviation 15.2	60.3 mL/min Standard Deviation 10.6
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 Month 6	63.0 mL/min Standard Deviation 15.1	58.7 mL/min Standard Deviation 12.2
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 Month 9	61.8 mL/min Standard Deviation 14.1	57.7 mL/min Standard Deviation 12.8
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 Month 12	60.8 mL/min Standard Deviation 14.2	57.5 mL/min Standard Deviation 14.1

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 cGFR (in mL/min/1.73 m2) = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 Month 9	67.4 mL/min Standard Deviation 14.9	61.7 mL/min Standard Deviation 15.1
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 Month 1	72.0 mL/min Standard Deviation 13.5	65.8 mL/min Standard Deviation 11.8
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 Month 3	68.7 mL/min Standard Deviation 12.2	63.3 mL/min Standard Deviation 12.3
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 Month 6	67.6 mL/min Standard Deviation 14.1	62.3 mL/min Standard Deviation 15.0
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 Month 12	67.0 mL/min Standard Deviation 14.8	60.5 mL/min Standard Deviation 14.4

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 1, 3, 6, 9, 12 For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 Month 3	76.1 mL/min Standard Deviation 17.6	70.1 mL/min Standard Deviation 16.0
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 Month 9	76.2 mL/min Standard Deviation 20.1	69.0 mL/min Standard Deviation 18.2
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 Month 12	76.2 mL/min Standard Deviation 20.6	68.4 mL/min Standard Deviation 17.8
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 Month 1	78.6 mL/min Standard Deviation 19.2	72.1 mL/min Standard Deviation 14.9
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 Month 6	76.2 mL/min Standard Deviation 19.3	69.1 mL/min Standard Deviation 17.5

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Incidence of patients experiencing a decline in GFR of \< 10, 10-15, 15-20, 20-25 and \> 25 mL/min from Baseline to Month 6 and 12calculated by the CKD-EPI method. Participants are counted in each decline level observed for that participant; this means participants may be counted in more than 1 decline level.

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 6: 10 - < 15 mL/min	9 incidences	18 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 6: < 10 mL/min	28 incidences	44 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 6: 15 - < 20 mL/min	6 incidences	11 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 6: 20 - < 25 mL/min	2 incidences	7 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 6: > 25 mL/min	3 incidences	7 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 12: < 10 mL/min	36 incidences	53 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 12: 10 - < 15 mL/min	10 incidences	27 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 12: 15 - < 20 mL/min	8 incidences	18 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 12: 20 - < 25 mL/min	8 incidences	9 incidences
Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12. Up to Month 12: > 25 mL/min	7 incidences	9 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Incidence of renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Renal Replacement Therapy at Month 6 and Month 12 up to Month 6	0 incidences	0 incidences
Incidence of Renal Replacement Therapy at Month 6 and Month 12 up to Month 12	0 incidences	0 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Population: Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. The outcome could not be analyzed because there were no incidences of renal replacement therapy

Time to renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6, Month 12

Incidence of acute rejection episodes at Month 6 and Month 12. This table counts multiple occurrences of rejection in the same patient as different incidents. Every incident is associated with both an A and a B classification. Classification A: Acute Rejection Grade 0 - none, Grade 1-minimal, Grade 2- mild, Grade 3-moderate, Grade 4-Severe; Classification B: Airway Inflammation-Grade 0-none, Grade 1R-low grade, Grade 2R-high grade, Grade X-ungradeable

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Acute Rejection Episodes at Month 6 and Month 12 Up to 6 months: Classification A	11 incidences	13 incidences
Incidence of Acute Rejection Episodes at Month 6 and Month 12 Up to 6 months: Classification B	11 incidences	13 incidences
Incidence of Acute Rejection Episodes at Month 6 and Month 12 6 to 12 months: Classification B	10 incidences	9 incidences
Incidence of Acute Rejection Episodes at Month 6 and Month 12 6 to 12 months: Classification A	10 incidences	9 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Incidence of graft loss/re-transplantation at Month 6 and Month 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12 Month 6	0 incidences	0 incidences
Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12 Month 12	1 incidences	1 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Incidence of Bronchiolitis obliterans syndrome (BOS) at Month 6 and Month 12 BOS 0 is FEV1 \> 90% of baseline and FEF25-75% \> 75% of baseline; BOS 0-p is FEV1 81-90% of baseline and/or FEF25-75% ≤ 75% of baseline; BOS 1 is FEV1 66-80% of baseline; BOS 2 is FEV1 51-65% of baseline; BOS 3 is FEV1 ≤ 50% of baseline

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS 0p	26 incidences	14 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS 1	3 incidences	5 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS (>/=1)	4 incidences	7 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS 0	35 incidences	38 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS 2	1 incidences	1 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - Total (all grades)	66 incidences	61 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS 0	36 incidences	40 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS 2	1 incidences	0 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 6 - BOS 3	0 incidences	2 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - Total (all grades)	66 incidences	61 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS 0p	26 incidences	14 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS 1	3 incidences	5 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS 3	1 incidences	3 incidences
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 Month 12 - BOS (>/=1)	5 incidences	9 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Population: Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.

Incidence of death at Month 6 and Month 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Death at Month 6 and Month 12 Month 6	0 incidences	0 incidences
Incidence of Death at Month 6 and Month 12 Month 12	3 incidences	1 incidences

SECONDARY outcome

Timeframe: Month 6, Month 12

Quality of Life (QoL, SF36) at Month 6 and Month 12 Scores can range from a minimum of 0 (maximum disability) to a maximum of 100 (no disability).

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Physical component summary score	47.2 scores on a scale Standard Deviation 8.8	47.7 scores on a scale Standard Deviation 7.1
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Mental component summary score	49.7 scores on a scale Standard Deviation 11.8	53.8 scores on a scale Standard Deviation 9.1
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Physical functioning	77.4 scores on a scale Standard Deviation 21.8	82.5 scores on a scale Standard Deviation 20.0
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: General health perception	66.7 scores on a scale Standard Deviation 17.3	65.8 scores on a scale Standard Deviation 20.3
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Vitality	65.7 scores on a scale Standard Deviation 19.4	69.9 scores on a scale Standard Deviation 17.5
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Physical component summary score	46.9 scores on a scale Standard Deviation 7.6	48.9 scores on a scale Standard Deviation 7.3
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Mental component summary score	51.5 scores on a scale Standard Deviation 10.8	52.6 scores on a scale Standard Deviation 8.1
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Physical functioning	78.8 scores on a scale Standard Deviation 20.9	84.1 scores on a scale Standard Deviation 16.8
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Role-Physical	71.1 scores on a scale Standard Deviation 23.2	77.1 scores on a scale Standard Deviation 24.2
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Bodily pain	76.4 scores on a scale Standard Deviation 27.9	81.3 scores on a scale Standard Deviation 23.4
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: General health perception	65.4 scores on a scale Standard Deviation 19.2	70.6 scores on a scale Standard Deviation 19.9
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Vitality	67.4 scores on a scale Standard Deviation 18.0	70.0 scores on a scale Standard Deviation 14.6
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6:Social functioning	84.1 scores on a scale Standard Deviation 22.6	88.9 scores on a scale Standard Deviation 17.6
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Role-Emotional	84.7 scores on a scale Standard Deviation 22.4	84.8 scores on a scale Standard Deviation 17.9
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 6: Mental health	78.5 scores on a scale Standard Deviation 17.2	81.0 scores on a scale Standard Deviation 12.8
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Role-Physical	68.3 scores on a scale Standard Deviation 26.8	78.0 scores on a scale Standard Deviation 22.9
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Bodily Pain	76.8 scores on a scale Standard Deviation 27.0	80.1 scores on a scale Standard Deviation 22.7
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Social functioning	82.3 scores on a scale Standard Deviation 23.0	90.5 scores on a scale Standard Deviation 16.1
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Role-Emotional	79.4 scores on a scale Standard Deviation 27.3	86.2 scores on a scale Standard Deviation 20.5
Quality of Life (QoL, SF36) at Month 6 and Month 12 Month 12: Mental health	75.4 scores on a scale Standard Deviation 18.2	81.8 scores on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: Month 6, Month 12

Exercise capacity (6MWT) at Month 6 and Month 12 Measured by the Borg Scale. THE BORG SCALE 0 is Nothing at all, 0.5 is Very, very slight (just noticeable); 1 is Very slight, 2 is Slight (light); 3 is Moderate; 4 is Somewhat severe; 5 is Severe (heavy), 7 is Very severe, 10 is Very, very severe (maximal)The higher the Borg score implies increased shortness of breath and/or increased fatigue.

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12 Month 6-Borg score - Before start of test	0.47 Scores on a scale Standard Deviation 0.78	0.39 Scores on a scale Standard Deviation 0.77
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12 Month 6-Borg score - At end of test	1.75 Scores on a scale Standard Deviation 1.58	1.64 Scores on a scale Standard Deviation 1.31
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12 Month 12-Borg score - Before start of test	0.38 Scores on a scale Standard Deviation 0.94	0.42 Scores on a scale Standard Deviation 0.79
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12 Month 12-Borg score - At end of test	2.08 Scores on a scale Standard Deviation 1.58	2.06 Scores on a scale Standard Deviation 1.85

SECONDARY outcome

Timeframe: up to Month 12

Incidence of treated of arterial hypertension up to Month 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Treated Arterial Hypertension up to Month 12 Month 1	2 incidences	1 incidences
Incidence of Treated Arterial Hypertension up to Month 12 Month 3	2 incidences	1 incidences
Incidence of Treated Arterial Hypertension up to Month 12 Month 6	2 incidences	1 incidences
Incidence of Treated Arterial Hypertension up to Month 12 Month 9	3 incidences	1 incidences
Incidence of Treated Arterial Hypertension up to Month 12 Month 12	4 incidences	1 incidences

SECONDARY outcome

Timeframe: up to Month 12

Incidence of Diabetes Mellitus up to Month 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Diabetes Mellitus up to Month 12 Month 1	0 incidences	0 incidences
Incidence of Diabetes Mellitus up to Month 12 Month 3	0 incidences	0 incidences
Incidence of Diabetes Mellitus up to Month 12 Month 6	0 incidences	1 incidences
Incidence of Diabetes Mellitus up to Month 12 Month 9	1 incidences	1 incidences
Incidence of Diabetes Mellitus up to Month 12 Month 12	1 incidences	1 incidences

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Trough levels of everolimus at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen centre specific CNI-based triple drug immunosuppression (IS)
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Month 1	4.2 ng/mL Standard Deviation 1.4	—
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Month 6	4.1 ng/mL Standard Deviation 1.2	—
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Month 9	4.5 ng/mL Standard Deviation 1.6	—
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Month 12	4.3 ng/mL Standard Deviation 1.1	—
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Month 3	4.4 ng/mL Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen centre specific CNI-based triple drug immunosuppression (IS)
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 1 Below Target Range	10 participant adherence 1.4	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 12 Above Target Range	9 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 1 Within Target Range	42 participant adherence 1.2	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 1 Above Target Range	14 participant adherence 1.2	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 3 Below Target Range	5 participant adherence 1.6	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 3 Within Target Range	41 participant adherence 1.1	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 3 Above Target Range	15 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 6 Below Target Range	7 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 6 Within Target Range	39 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 6 Above Target Range	12 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 9 Below Target Range	5 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 9 Within Target Range	34 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 9 Above Target Range	13 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 12 Below Target Range	3 participant adherence	—
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Month 12 Within Target Range	38 participant adherence	—

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 1	61 ng/mL Standard Deviation 21.83	106 ng/mL Standard Deviation 21.25
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 3	59.65 ng/mL Standard Deviation 20.43	109 ng/mL Standard Deviation 24.95
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 6	58.50 ng/mL Standard Deviation 12.84	103 ng/mL Standard Deviation 32.95
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 9	57.59 ng/mL Standard Deviation 23.26	107 ng/mL Standard Deviation 29.13
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 12	69.33 ng/mL Standard Deviation 48.41	108 ng/mL Standard Deviation 27.82

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 1 Above Target Range	3 participant adherence 12.84	0 participant adherence 32.95
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 3 Below Target Range	0 participant adherence 23.26	4 participant adherence 29.13
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 3 Above Target Range	2 participant adherence	0 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 6 Within Target Range	18 participant adherence	8 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 6 Above Target Range	2 participant adherence	0 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 12 Above Target Range	5 participant adherence	0 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 1 Below Target Range	0 participant adherence 21.83	8 participant adherence 21.25
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 1 Within Target Range	18 participant adherence 20.43	8 participant adherence 24.95
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 3 Within Target Range	18 participant adherence 48.41	10 participant adherence 27.82
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 6 Below Target Range	0 participant adherence	6 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 9 Below Target Range	0 participant adherence	4 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 9 Within Target Range	16 participant adherence	9 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 9 Above Target Range	1 participant adherence	0 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 12 Below Target Range	0 participant adherence	3 participant adherence
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 Month 12 Within Target Range	16 participant adherence	10 participant adherence

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 1	5.07 ng/mL Standard Deviation 1.80	10.44 ng/mL Standard Deviation 2.73
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 3	5.18 ng/mL Standard Deviation 2.02	10.53 ng/mL Standard Deviation 2.88
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 6	4.70 ng/mL Standard Deviation 1.98	10.09 ng/mL Standard Deviation 3.37
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 9	5.78 ng/mL Standard Deviation 4.18	10.67 ng/mL Standard Deviation 3.44
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 12	5.19 ng/mL Standard Deviation 2.36	9.66 ng/mL Standard Deviation 3.01

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 1 Within Target Range	24 participant adherence 20.43	45 participant adherence 24.95
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 1 Above Target Range	17 participant adherence 12.84	0 participant adherence 32.95
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 1 Below Target Range	3 participant adherence 21.83	0 participant adherence 21.25
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 3 Below Target Range	3 participant adherence 23.26	0 participant adherence 29.13
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 3 Within Target Range	23 participant adherence 48.41	47 participant adherence 27.82
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 3 Above Target Range	18 participant adherence	0 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 6 Below Target Range	5 participant adherence	1 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 6 Within Target Range	23 participant adherence	45 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 6 Above Target Range	12 participant adherence	0 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 9 Below Target Range	2 participant adherence	0 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 9 Within Target Range	18 participant adherence	46 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 9 Above Target Range	18 participant adherence	0 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 12 Below Target Range	3 participant adherence	0 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 12 Within Target Range	23 participant adherence	47 participant adherence
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 Month 12 Above Target Range	15 participant adherence	0 participant adherence

SECONDARY outcome

Timeframe: Month 12

Incidence of bacterial, viral, and fungal infections at Month 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Incidence of Bacterial, Viral, and Fungal Infections at Month 12 Bacterial infections	3 incidences	4 incidences
Incidence of Bacterial, Viral, and Fungal Infections at Month 12 Viral infections	14 incidences	20 incidences
Incidence of Bacterial, Viral, and Fungal Infections at Month 12 Fungal infections	3 incidences	0 incidences

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Triglyceride levels at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Triglyceride Levels at Month 1, 3, 6, 9, 12 Month 1	2.6 mmol/L Standard Deviation 1.4	2.0 mmol/L Standard Deviation 0.9
Triglyceride Levels at Month 1, 3, 6, 9, 12 Month 3	2.7 mmol/L Standard Deviation 1.3	2.1 mmol/L Standard Deviation 1.0
Triglyceride Levels at Month 1, 3, 6, 9, 12 Month 6	2.6 mmol/L Standard Deviation 1.2	2.0 mmol/L Standard Deviation 1.1
Triglyceride Levels at Month 1, 3, 6, 9, 12 Month 9	2.7 mmol/L Standard Deviation 1.3	2.0 mmol/L Standard Deviation 1.0
Triglyceride Levels at Month 1, 3, 6, 9, 12 Month 12	2.7 mmol/L Standard Deviation 1.5	2.1 mmol/L Standard Deviation 0.9

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

Total Cholesterol levels at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 1	0.8 mmol/L Standard Deviation 0.8	-0.2 mmol/L Standard Deviation 0.7
Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 3	1.0 mmol/L Standard Deviation 0.8	-0.1 mmol/L Standard Deviation 0.9
Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 6	1.1 mmol/L Standard Deviation 0.9	-0.2 mmol/L Standard Deviation 0.8
Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 9	1.1 mmol/L Standard Deviation 0.9	-0.1 mmol/L Standard Deviation 0.9
Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 12	0.8 mmol/L Standard Deviation 1.1	-0.1 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

LDL Cholesterol levels at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 9	0.8 mmol/L Standard Deviation 0.8	0.1 mmol/L Standard Deviation 0.7
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 12	0.5 mmol/L Standard Deviation 0.9	0.1 mmol/L Standard Deviation 0.6
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 1	0.4 mmol/L Standard Deviation 0.8	0.0 mmol/L Standard Deviation 0.5
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 3	0.6 mmol/L Standard Deviation 0.7	-0.0 mmol/L Standard Deviation 0.6
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 6	0.7 mmol/L Standard Deviation 0.8	-0.0 mmol/L Standard Deviation 0.6

SECONDARY outcome

Timeframe: Month 1, 3, 6, 9, 12

HDL Cholesterol levels at Month 1, 3, 6, 9, 12

Outcome measures

Outcome measures
Measure	Quadruple Low Level IS Regimen n=67 Participants quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 Participants centre specific CNI-based triple drug immunosuppression (IS)
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 1	0.1 mmol/L Standard Deviation 0.3	-0.1 mmol/L Standard Deviation 0.3
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 3	0.1 mmol/L Standard Deviation 0.3	-0.0 mmol/L Standard Deviation 0.4
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 6	0.1 mmol/L Standard Deviation 0.4	-0.0 mmol/L Standard Deviation 0.4
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 9	0.0 mmol/L Standard Deviation 0.4	-0.0 mmol/L Standard Deviation 0.4
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 Month 12	0.0 mmol/L Standard Deviation 0.5	-0.0 mmol/L Standard Deviation 0.4

Adverse Events

Quadruple Low Level IS Regimen

Serious events: 29 serious events

Other events: 62 other events

Deaths: 0 deaths

Centre Specific Triple IS Regimen

Serious events: 22 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 8627788300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single- site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Quadruple Low Level IS Regimen n=67 participants at risk quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids	Centre Specific Triple IS Regimen n=63 participants at risk centre specific CNI-based triple drug immunosuppression (IS)
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	1.5% 1/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Skin and subcutaneous tissue disorders ACNE	17.9% 12/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	1.6% 1/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Vascular disorders HYPERTENSION	10.4% 7/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Blood and lymphatic system disorders ANAEMIA	9.0% 6/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	4.8% 3/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Blood and lymphatic system disorders LEUKOPENIA	22.4% 15/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	30.2% 19/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Gastrointestinal disorders DIARRHOEA	13.4% 9/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	15.9% 10/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Gastrointestinal disorders NAUSEA	13.4% 9/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	15.9% 10/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Gastrointestinal disorders VOMITING	7.5% 5/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
General disorders CHEST PAIN	3.0% 2/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
General disorders OEDEMA PERIPHERAL	28.4% 19/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	15.9% 10/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
General disorders PYREXIA	1.5% 1/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Infections and infestations CYTOMEGALOVIRUS INFECTION	14.9% 10/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	17.5% 11/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	3.0% 2/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Infections and infestations NASOPHARYNGITIS	25.4% 17/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	27.0% 17/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Infections and infestations RESPIRATORY TRACT INFECTION	11.9% 8/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	11.1% 7/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Infections and infestations URINARY TRACT INFECTION	6.0% 4/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	3.2% 2/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Injury, poisoning and procedural complications COMPLICATIONS OF TRANSPLANTED LUNG	0.00% 0/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Investigations BRONCHOALVEOLAR LAVAGE ABNORMAL	4.5% 3/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	9.5% 6/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Investigations C-REACTIVE PROTEIN INCREASED	3.0% 2/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Investigations FORCED EXPIRATORY VOLUME DECREASED	10.4% 7/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	12.7% 8/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Investigations PULMONARY FUNCTION TEST DECREASED	9.0% 6/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	4.8% 3/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Musculoskeletal and connective tissue disorders ARTHRALGIA	3.0% 2/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Musculoskeletal and connective tissue disorders BACK PAIN	3.0% 2/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	11.9% 8/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	7.9% 5/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Nervous system disorders HEADACHE	11.9% 8/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	14.3% 9/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Nervous system disorders MIGRAINE	4.5% 3/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Respiratory, thoracic and mediastinal disorders COUGH	14.9% 10/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	11.1% 7/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	6.0% 4/67 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.	6.3% 4/63 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until 12 months.