Kidney TransplantationPhase 3NCT00514514
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
A Phase 3 study testing Everolimus, Myfortic and Sandimmun Optoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 18 sites in 2 countries.
Trial summary
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Everolimus, Myfortic and Sandimmun Optoral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2007to Jun 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged 18 - 70 years
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Who cannot join
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Donor age: < 5 years or > 70 years
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Germany17 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 51109
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Frankfurt am Main, 60596
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hannover Muenden, 34346
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Kaiserslautern, 67655
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
München, 81377
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Regensburg, 93053
About this study
Official title: Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
- Conditions
- Kidney Transplantation
- Being tested
- Everolimus, Myfortic, Sandimmun Optoral, Simulect®
- Keywords
- Everolimus, mycophenolate, CNI-free, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen
MyforticDrug
Also called Enteric Coated Mycophenolate Sodium
1 tablet containing 180 mg or 360 mg
Dosing schedule:
Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day)
Sandimmun OptoralDrug
Also called Cyclosporine A
1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level
Simulect®Drug
Also called Basiliximab
Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4
| Study group | Role | What they receive |
|---|---|---|
| CNI standard regimen | Active comparator | Myfortic, Sandimmun Optoral and corticosteroids Receives: Drug: Myfortic; Drug: Sandimmun Optoral; Drug: Simulect® |
| CNI free regimen | Experimental | CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids Receives: Drug: Everolimus; Drug: Myfortic; Drug: Sandimmun Optoral |
| CNI low regimen | Active comparator | CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids Receives: Drug: Everolimus; Drug: Sandimmun Optoral |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen
Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted
Measured: From randomization at BL2 (Month 3) to Month 12 post-transplant
Secondary outcomes (12)
GFR Via Nankivell Formula at Month 12 - All Regimens
Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.
Measured: From randomization at BL2 (Month 3) to Month 12 post-transplant
GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method
Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:
For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.
Measured: From randomization at BL2 (Month 3) to Month 12 post-transplant
GFR at Month 12 Utilizing Cockcroft-Gault Formula
Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Measured: From randomization at BL2 (Month 3) to Month 12 post-transplant
Mean Change in Serum Creatinine From Month 3 to Month 12
Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Measured: From randomization at BL2 (Month 3) to Month 12 post-transplant
Efficacy Event Data From Baseline 2 (Month 3) to Month 6
Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).
Measured: From Baseline 2 (Month 3) to Month 6
Efficacy Event Data Baseline 2 (Month 3) to Month 12
Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).
Measured: From Baseline 2 (Month 3) to Month 12
Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)
The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.
Measured: From Baseline 2 (Month 3) to Month 12
GFR Calculated Via Nankivell Formula at Month 60
Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.
Measured: From randomization at BL2 (Month 3) to Month 60
GFR at Month 60 Utilizing Cockcroft-Gault Formula
Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Measured: From randomization at BL2 (Month 3) to Month 60 post-transplant
GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method
Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:
For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.
Measured: From randomization at BL2 (Month 3) to Month 60 post-transplant
Mean Change in Serum Creatinine From Month 3 to Month 60
Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Measured: From randomization at BL2 (Month 3) to Month 60 post-transplant
Efficacy Event Data After Month 12 to Month 60
Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).
Measured: Events starting after Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2015
- Study completionJun 2015
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 Kidney 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
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514514
- Sponsor's protocol ID
- CRAD001ADE13
- Other IDs
- 2006-007021-32
- Status last verified
- Nov 2016
- First submitted
- 9 Aug 2007
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Sommerer C, Witzke O, Lehner F, Arns W, Reinke P, Eisenberger U, Vogt B, Heller K, Jacobi J, Guba M, Stahl R, Hauser IA, Kliem V, Wuthrich RP, Muhlfeld A, Suwelack B, Duerr M, Paulus EM, Zeier M, Porstner M, Budde K; ZEUS and HERAKLES study investigators. Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials. BMC Nephrol. 2018 Sep 19;19(1):237. doi: 10.1186/s12882-018-1031-1.
PubMed 30231851Budde K, Zeier M, Witzke O, Arns W, Lehner F, Guba M, Jacobi J, Kliem V, Reinke P, Hauser IA, Vogt B, Stahl R, Rath T, Duerr M, Paulus EM, May C, Porstner M, Sommerer C; HERAKLES Study Group. Everolimus with cyclosporine withdrawal or low-exposure cyclosporine in kidney transplantation from Month 3: a multicentre, randomized trial. Nephrol Dial Transplant. 2017 Jun 1;32(6):1060-1070. doi: 10.1093/ndt/gfx075.
PubMed 28605781
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen
- ClinicalTrials.gov ID
- NCT00514514
- Acronym / sponsor ID
- CRAD001ADE13
- Conditions
- Kidney Transplantation
- Keywords
- Everolimus, mycophenolate, CNI-free, kidney transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNI standard regimen | Active comparator | Drug: Myfortic, Drug: Sandimmun Optoral, Drug: Simulect®Myfortic, Sandimmun Optoral and corticosteroids |
| CNI free regimen | Experimental | Drug: Everolimus, Drug: Myfortic, Drug: Sandimmun OptoralCNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids |
| CNI low regimen | Active comparator | Drug: Everolimus, Drug: Sandimmun OptoralCNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, aged 18 - 70 years
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Key exclusion criteria (6 listed)
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Donor age: < 5 years or > 70 years
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
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 |
|---|---|---|
| EverolimusAlso: CerticanTablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen | Drug | CNI free regimen, CNI low regimen |
| MyforticAlso: Enteric Coated Mycophenolate Sodium1 tablet containing 180 mg or 360 mg Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day) | Drug | CNI free regimen, CNI standard regimen |
| Sandimmun OptoralAlso: Cyclosporine A1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level | Drug | CNI free regimen, CNI low regimen, CNI standard regimen |
| Simulect®Also: BasiliximabLyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4 | Drug | CNI standard regimen |
Primary outcome
GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen
Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant
Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted
12 secondary outcomes
GFR Via Nankivell Formula at Month 12 - All Regimens
Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant
GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method
Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant
GFR at Month 12 Utilizing Cockcroft-Gault Formula
Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant
Mean Change in Serum Creatinine From Month 3 to Month 12
Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant
Efficacy Event Data From Baseline 2 (Month 3) to Month 6
Time frame: From Baseline 2 (Month 3) to Month 6
Efficacy Event Data Baseline 2 (Month 3) to Month 12
Time frame: From Baseline 2 (Month 3) to Month 12
Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)
Time frame: From Baseline 2 (Month 3) to Month 12
GFR Calculated Via Nankivell Formula at Month 60
Time frame: From randomization at BL2 (Month 3) to Month 60
GFR at Month 60 Utilizing Cockcroft-Gault Formula
Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant
GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method
Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant
Mean Change in Serum Creatinine From Month 3 to Month 60
Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant
Efficacy Event Data After Month 12 to Month 60
Time frame: Events starting after Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30231851Sommerer C, Witzke O, Lehner F, Arns W, Reinke P, Eisenberger U, Vogt B, Heller K, Jacobi J, Guba M, Stahl R, Hauser IA, Kliem V, Wuthrich RP, Muhlfeld A, Suwelack B, Duerr M, Paulus EM, Zeier M, Porstner M, Budde K; ZEUS and HERAKLES study investigators. Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials. BMC Nephrol. 2018 Sep 19;19(1):237. doi: 10.1186/s12882-018-1031-1.
- Derived from this study: PubMed 28605781Budde K, Zeier M, Witzke O, Arns W, Lehner F, Guba M, Jacobi J, Kliem V, Reinke P, Hauser IA, Vogt B, Stahl R, Rath T, Duerr M, Paulus EM, May C, Porstner M, Sommerer C; HERAKLES Study Group. Everolimus with cyclosporine withdrawal or low-exposure cyclosporine in kidney transplantation from Month 3: a multicentre, randomized trial. Nephrol Dial Transplant. 2017 Jun 1;32(6):1060-1070. doi: 10.1093/ndt/gfx075.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis study director
Novartis
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus, Myfortic and Sandimmun Optoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 18 sites in 2 countries.
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 4 inclusion and 6 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Switzerland. 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 18 Jan 2017). 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?
GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen (time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant). 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 NCT00514514, 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 18 Jan 2017.