Phase 3
N=130
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01404325 ↗Enrolled (actual)
130
Serious AEs
39.2%
Results posted
Mar 2019
Primary outcome: Primary: Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months — 64.5; 54.6 mL/min — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- standard therapy (Drug); Everolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months |
64.5; 54.6 | <0.0001 sig |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12 |
73.5; 67.1; 70.4; 64.3; 69.2; 63.1 | — |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12 |
68.5; 61.8; 65.7; 60.3; 63.0; 58.7 | — |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 |
72.0; 65.8; 68.7; 63.3; 67.6; 62.3 | — |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12 |
78.6; 72.1; 76.1; 70.1; 76.2; 69.1 | — |
| SECONDARY 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. |
28; 44; 9; 18; 6; 11 | — |
| SECONDARY Incidence of Renal Replacement Therapy at Month 6 and Month 12 |
0; 0; 0; 0 | — |
| SECONDARY Time to Renal Replacement Therapy at Month 6 and Month 12 |
— | — |
| SECONDARY Incidence of Acute Rejection Episodes at Month 6 and Month 12 |
11; 13; 11; 13; 10; 9 | — |
| SECONDARY Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12 |
0; 0; 1; 1 | — |
| SECONDARY Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12 |
66; 61; 36; 40; 26; 14 | — |
| SECONDARY Incidence of Death at Month 6 and Month 12 |
0; 0; 3; 1 | — |
| SECONDARY Quality of Life (QoL, SF36) at Month 6 and Month 12 |
46.9; 48.9; 51.5; 52.6; 78.8; 84.1 | — |
| SECONDARY Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12 |
0.47; 0.39; 1.75; 1.64; 0.38; 0.42 | — |
| SECONDARY Incidence of Treated Arterial Hypertension up to Month 12 |
2; 1; 2; 1; 2; 1 | — |
| SECONDARY Incidence of Diabetes Mellitus up to Month 12 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 |
4.2; 4.4; 4.1; 4.5; 4.3 | — |
| SECONDARY Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 |
10; 42; 14; 5; 41; 15 | — |
| SECONDARY Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 |
61; 106; 59.65; 109; 58.50; 103 | — |
| SECONDARY Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12 |
0; 8; 18; 8; 3; 0 | — |
| SECONDARY Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 |
5.07; 10.44; 5.18; 10.53; 4.70; 10.09 | — |
| SECONDARY Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12 |
3; 0; 24; 45; 17; 0 | — |
| SECONDARY Incidence of Bacterial, Viral, and Fungal Infections at Month 12 |
3; 4; 14; 20; 3; 0 | — |
| SECONDARY Triglyceride Levels at Month 1, 3, 6, 9, 12 |
2.6; 2.0; 2.7; 2.1; 2.6; 2.0 | — |
| SECONDARY Total Cholesterol Levels at Month 1, 3, 6, 9, 12 |
0.8; -0.2; 1.0; -0.1; 1.1; -0.2 | — |
| SECONDARY Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 |
0.4; 0.0; 0.6; -0.0; 0.7; -0.0 | — |
| SECONDARY High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 |
0.1; -0.1; 0.1; -0.0; 0.1; -0.0 | — |
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.
Eligibility Criteria
Inclusion criteria
- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment
Exclusion criteria
- Patients with thrombocytopenia (platelets 350 mg/dL; > 9.1 mmol/L) or hypertriglyceridemia (> 750 mg/dL; > 8.5 mmol/L) at time of screening
- Patients with a history of malignancy of any organ system, treated or untreated, during the last five years, whether or not there is evidence of local recurrence or metastases, except squamous or basal cell carcinoma of the skin Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01404325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.