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

Phase 3

Completed

Conditions: Lung Transplantation

Interventions: Drug: Everolimus
Drug: standard therapy

Registration Number: NCT01404325

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadruple low level IS regimen	Everolimus	quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
Centre specific triple IS regimen	standard therapy	centre specific CNI-based triple drug immunosuppression (IS)

Primary Outcome Measures

Name	Time	Method
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months	Month 12	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

Secondary Outcome Measures

Name	Time	Method
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	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
Incidence of Diabetes Mellitus up to Month 12	up to Month 12	Incidence of Diabetes Mellitus up to Month 12
Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12	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
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12	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.
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12	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)
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.	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.
Incidence of Renal Replacement Therapy at Month 6 and Month 12	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
Time to Renal Replacement Therapy at Month 6 and Month 12	Month 6, Month 12	Time to renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required
Incidence of Acute Rejection Episodes at Month 6 and Month 12	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
Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12	Month 6, Month 12	Incidence of graft loss/re-transplantation at Month 6 and Month 12
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12	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
Incidence of Death at Month 6 and Month 12	Month 6, Month 12	Incidence of death at Month 6 and Month 12
Quality of Life (QoL, SF36) at Month 6 and Month 12	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).
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12	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.
Incidence of Treated Arterial Hypertension up to Month 12	up to Month 12	Incidence of treated of arterial hypertension up to Month 12
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12
Triglyceride Levels at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Triglyceride levels at Month 1, 3, 6, 9, 12
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	LDL Cholesterol levels at Month 1, 3, 6, 9, 12
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	HDL Cholesterol levels at Month 1, 3, 6, 9, 12
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Trough levels of everolimus at Month 1, 3, 6, 9, 12
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12
Incidence of Bacterial, Viral, and Fungal Infections at Month 12	Month 12	Incidence of bacterial, viral, and fungal infections at Month 12
Total Cholesterol Levels at Month 1, 3, 6, 9, 12	Month 1, 3, 6, 9, 12	Total Cholesterol levels at Month 1, 3, 6, 9, 12