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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01404325
Other study ID # CRAD001ADE36
Secondary ID 2011-001539-21
Status Completed
Phase Phase 3
First received
Last updated
Start date February 1, 2012
Est. completion date January 5, 2017

Study information

Verified date November 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date January 5, 2017
Est. primary completion date January 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment

Exclusion criteria:

- Patients with thrombocytopenia (platelets <100,000/mm³), with an absolute neutrophil count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl at time of screening

- Patients with uncontrolled hypercholesterolemia (> 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
standard therapy
centre specific CNI-based triple drug immunosuppression
Everolimus
quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Locations

Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Homburg
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Muenchen

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months 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/?, 1)a × max(Scr/?, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, ? is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1 Month 12
Secondary Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 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/?, 1)a × max(Scr/?, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, ? is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1 Month 1, 3, 6, 9, 12
Secondary 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) according to Cystatin C-based Hoek's formula at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) 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 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. Month 1, 3, 6, 9, 12
Secondary Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at 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) Month 1, 3, 6, 9, 12
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. 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. Baseline, Month 6, Month 12
Secondary Incidence of Renal Replacement Therapy at Month 6 and 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 Month 6, Month 12
Secondary Time to Renal Replacement Therapy at Month 6 and 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 Month 6, Month 12
Secondary Incidence of Acute Rejection Episodes at Month 6 and 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
Month 6, Month 12
Secondary Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12 Incidence of graft loss/re-transplantation at Month 6 and Month 12 Month 6, Month 12
Secondary Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and 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 Month 6, Month 12
Secondary Incidence of Death at Month 6 and Month 12 Incidence of death at Month 6 and Month 12 Month 6, Month 12
Secondary Quality of Life (QoL, SF36) at Month 6 and 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). Month 6, Month 12
Secondary Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and 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. Month 6, Month 12
Secondary Incidence of Treated Arterial Hypertension up to Month 12 Incidence of treated of arterial hypertension up to Month 12 up to Month 12
Secondary Incidence of Diabetes Mellitus up to Month 12 Incidence of Diabetes Mellitus up to Month 12 up to Month 12
Secondary Trough Levels of Everolimus at Month 1, 3, 6, 9, 12 Trough levels of everolimus at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12 Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Trough Levels of Cyclosporine A (CsA) 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
Secondary Adherence to Target Ranges 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
Secondary Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12 Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Adherence to Target Ranges 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
Secondary Incidence of Bacterial, Viral, and Fungal Infections at Month 12 Incidence of bacterial, viral, and fungal infections at Month 12 Month 12
Secondary Triglyceride Levels at Month 1, 3, 6, 9, 12 Triglyceride levels at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Total Cholesterol Levels at Month 1, 3, 6, 9, 12 Total Cholesterol levels at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 LDL Cholesterol levels at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
Secondary High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12 HDL Cholesterol levels at Month 1, 3, 6, 9, 12 Month 1, 3, 6, 9, 12
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