Lung TransplantationPhase 34EVERLUNGNCT01404325
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
A Phase 3 study testing standard therapy and Everolimus in people with Lung Transplantation, run by Novartis Pharmaceuticals at 9 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- standard therapy and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 9 sitesGermany
- Study dates
- 1 Feb 2012to 5 Jan 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
München, 81377
About this study
Official title: A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.
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.
- Conditions
- Lung Transplantation
- Being tested
- standard therapy, Everolimus
- Keywords
- Lung transplantation, everolimus, kidney function, renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapyDrug
centre specific CNI-based triple drug immunosuppression
EverolimusDrug
Also called RAD001
quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids
| Study group | Role | What they receive |
|---|---|---|
| Quadruple low level IS regimen | Experimental | quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids Receives: Drug: Everolimus |
| Centre specific triple IS regimen | Experimental | centre specific CNI-based triple drug immunosuppression (IS) Receives: Drug: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/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
Measured: Month 12
Secondary outcomes (26)
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/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
Measured: 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) according to Cystatin C-based Hoek's formula at Month 1, 3, 6, 9, 12
Measured: 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
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.
Measured: Month 1, 3, 6, 9, 12
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)
Measured: Month 1, 3, 6, 9, 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 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.
Measured: Baseline, Month 6, Month 12
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
Measured: Month 6, Month 12
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
Measured: Month 6, Month 12
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
Measured: Month 6, Month 12
Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12
Incidence of graft loss/re-transplantation at Month 6 and Month 12
Measured: Month 6, Month 12
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
Measured: Month 6, Month 12
Incidence of Death at Month 6 and Month 12
Incidence of death at Month 6 and Month 12
Measured: Month 6, Month 12
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).
Measured: Month 6, Month 12
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.
Measured: Month 6, Month 12
Incidence of Treated Arterial Hypertension up to Month 12
Incidence of treated of arterial hypertension up to Month 12
Measured: up to Month 12
Incidence of Diabetes Mellitus up to Month 12
Incidence of Diabetes Mellitus up to Month 12
Measured: up to Month 12
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12
Trough levels of everolimus at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
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
Measured: Month 1, 3, 6, 9, 12
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
Measured: Month 1, 3, 6, 9, 12
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
Measured: Month 1, 3, 6, 9, 12
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12
Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
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
Measured: Month 1, 3, 6, 9, 12
Incidence of Bacterial, Viral, and Fungal Infections at Month 12
Incidence of bacterial, viral, and fungal infections at Month 12
Measured: Month 12
Triglyceride Levels at Month 1, 3, 6, 9, 12
Triglyceride levels at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
Total Cholesterol Levels at Month 1, 3, 6, 9, 12
Total Cholesterol levels at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12
LDL Cholesterol levels at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12
HDL Cholesterol levels at Month 1, 3, 6, 9, 12
Measured: Month 1, 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study start1 Feb 2012
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404325
- Sponsor's protocol ID
- CRAD001ADE36
- Other IDs
- 2011-001539-21
- Acronym
- 4EVERLUNG
- Status last verified
- Nov 2018
- First submitted
- 13 Jul 2011
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kneidinger N, Valtin C, Hettich I, Frye BC, Wald A, Wilkens H, Bessa V, Gottlieb J. Five-year Outcome of an Early Everolimus-based Quadruple Immunosuppression in Lung Transplant Recipients: Follow-up of the 4EVERLUNG Study. Transplantation. 2022 Sep 1;106(9):1867-1874. doi: 10.1097/TP.0000000000004095. Epub 2022 Mar 8.
PubMed 35283454Gottlieb J, Neurohr C, Muller-Quernheim J, Wirtz H, Sill B, Wilkens H, Bessa V, Knosalla C, Porstner M, Capusan C, Struber M. A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation. Am J Transplant. 2019 Jun;19(6):1759-1769. doi: 10.1111/ajt.15251. Epub 2019 Feb 5.
PubMed 30615259
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.
- ClinicalTrials.gov ID
- NCT01404325
- Acronym / sponsor ID
- 4EVERLUNG / CRAD001ADE36
- Conditions
- Lung Transplantation
- Keywords
- Lung transplantation, everolimus, kidney function, renal function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadruple low level IS regimen | Experimental | Drug: Everolimusquadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids |
| Centre specific triple IS regimen | Experimental | Drug: standard therapycentre specific CNI-based triple drug immunosuppression (IS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard therapycentre specific CNI-based triple drug immunosuppression | Drug | Centre specific triple IS regimen |
| EverolimusAlso: RAD001quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids | Drug | Quadruple low level IS regimen |
Primary outcome
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months
Time frame: 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
26 secondary outcomes
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12
Time frame: 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
Time frame: 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
Time frame: Month 1, 3, 6, 9, 12
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 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 12.
Time frame: Baseline, Month 6, Month 12
Incidence of Renal Replacement Therapy at Month 6 and Month 12
Time frame: Month 6, Month 12
Time to Renal Replacement Therapy at Month 6 and Month 12
Time frame: Month 6, Month 12
Incidence of Acute Rejection Episodes at Month 6 and Month 12
Time frame: Month 6, Month 12
Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12
Time frame: Month 6, Month 12
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12
Time frame: Month 6, Month 12
Incidence of Death at Month 6 and Month 12
Time frame: Month 6, Month 12
Quality of Life (QoL, SF36) at Month 6 and Month 12
Time frame: Month 6, Month 12
Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12
Time frame: Month 6, Month 12
Incidence of Treated Arterial Hypertension up to Month 12
Time frame: up to Month 12
Incidence of Diabetes Mellitus up to Month 12
Time frame: up to Month 12
Trough Levels of Everolimus at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Incidence of Bacterial, Viral, and Fungal Infections at Month 12
Time frame: Month 12
Triglyceride Levels at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Total Cholesterol Levels at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12
Time frame: Month 1, 3, 6, 9, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35283454Kneidinger N, Valtin C, Hettich I, Frye BC, Wald A, Wilkens H, Bessa V, Gottlieb J. Five-year Outcome of an Early Everolimus-based Quadruple Immunosuppression in Lung Transplant Recipients: Follow-up of the 4EVERLUNG Study. Transplantation. 2022 Sep 1;106(9):1867-1874. doi: 10.1097/TP.0000000000004095. Epub 2022 Mar 8.
- Derived from this study: PubMed 30615259Gottlieb J, Neurohr C, Muller-Quernheim J, Wirtz H, Sill B, Wilkens H, Bessa V, Knosalla C, Porstner M, Capusan C, Struber M. A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation. Am J Transplant. 2019 Jun;19(6):1759-1769. doi: 10.1111/ajt.15251. Epub 2019 Feb 5.
- Individual participant dataSharing planned: 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.
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Lung Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard therapy and Everolimus in people with Lung Transplantation, run by Novartis Pharmaceuticals at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01404325, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.