Transplant; Failure, KidneyPhase 3NCT01680861
Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium
A Phase 3 study testing Tacrolimus, Everolimus and Enteric Coated Mycophenolate Sodium (EC-MPS) in people with Transplant; Failure, Kidney, run by Gaetano Ciancio at 1 site in United States.
Trial summary
A recent therapeutic strategy following renal transplantation includes simultaneous use of reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic, antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with the goals of reducing/avoiding CNI nephrotoxicity… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant; Failure, Kidney
- What is being tested?
- Tacrolimus, Everolimus and Enteric Coated Mycophenolate Sodium (EC-MPS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight > 40 kg.
- Deceased donor (SCD) or LD.
- Donor-recipient 1 haplotype matched pairs with a minimum matching of 1 HLA DR antigen.
- Negative standard cross match for T cells.
- Pretransplant panel reactive antibodies of < 30%.
- Graft required to be functional, producing at least 100ml of urine within 24hr after transplantation.
Who cannot join
- Previously received or is receiving an organ transplant other than a kidney.
- Donor organ with a cold ischemic time > 48 hours.
- ABO incompatible donor kidney.
- Recipients of T cell, or B cell crossmatch positive transplant.
- Panel reactive antibody (PRA) >30%
- HIV or Hepatitis C virus, or Hepatitis B virus antigenemia.
Show all 14Show fewer
- Current malignancy or a history of malignancy
- Liver disease
- Uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer
- Use of warfarin, fluvastatin, or herbal supplements during the study.
- Use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
- Hypersensitivity to thymoglobulin, IL-2 receptor inhibitor monoclonal antibodies, tacrolimus, everolimus, MPA, or corticosteroids.
- Pregnant or lactating.
- Abnormal screening/baseline labs WBC, platelet count, triglycerides, and cholesterol Double kidneys,ECD, pediatric en-block, and donation after cardiac death (DCD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label Trial of Tacrolimus/Everolimus vs. Tacrolimus/Enteric-Coated Mycophenolate Sodium to Prevent Biopsy-Proven Acute Rejection and Chronic Allograft Injury in Adult, Primary Kidney Transplantation
A recent therapeutic strategy following renal transplantation includes simultaneous use of reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic, antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to more favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal has also been used in the attempt to avoid well-known side effects while maintaining favorable patient and graft survival.8-10 While the investigators center and numerous other centers have also included single agent, antibody induction utilizing the lymphodepleting polyclonal antibody rabbit anti-human thymocyte globulin (ATG), nondepleting human anti-interleukin-2 receptor (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or lymphodepleting humanized anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now suggests that an even more effective induction strategy may include the combined use of more than one induction agent (each with fewer doses than if used alone), with the goal of bringing the kidney transplant recipient even closer (through more effectively timed lymphodepletion) to an optimally immunosuppressed state, allowing further reduction in long-term maintenance drug dosing.18-25 The investigators have now successfully used dual ATG/Dac induction therapy in both kidney-alone23-24 and simultaneous kidney-pancreas (SPK) transplantation,18-20 and a recent report from the investigators center of kidney-alone and SPK recipients shows that the addition of anti-CD25 to ATG for induction therapy more effectively delays the return of peripheral blood CD25+ cells.25 In the kidney-alone recipient study 3 doses of ATG were combined with 2 doses of Dac for induction,23-24 vs. the investigators previous studies utilizing single agent induction with 7 doses of ATG or 5 doses of Dac.4,16,17 Successful combination of ATG/basiliximab as dual induction in kidney transplantation has also been reported elsewhere,21-22 along with equivalency in clinical outcomes using daclizumab vs. basiliximab.13
Read the detailed description
- Primary Objectives:
- The percentage of patients who develop chronic allograft injury (CAI) progression during the first 12 months post-transplant protocol biopsy (i.e., higher grade of IF/TA at either the 6 or 12 month protocol biopsy in comparison with the baseline biopsy).
- The incidence rate of biopsy-proven acute rejection (BPAR) during the first 12 months post-transplant.
- Secondary Objectives:
- Adverse events including graft loss (death-censored and death-uncensored), and death at 12 months post-transplant.
- Incidence rate and severity (severity of CAI at 12 months as well), based upon careful review of all clinically indicated and protocol biopsies.
- Renal function as determined by serum creatinine and estimated glomerular filtration rate (eGFR) (calculated using the abbreviated MDRD formula) at 12, months post-transplant. Use of multivariable analysis to compare renal function as well as BPAR and CAI progression will also be performed (particularly, after adjusting for the significant effects of donor age, recipient age, race/ethnicity, and any other predictors).
- Adverse events including withholding (for ≥ 28 days) or discontinuance of study medications (and reasons why), new onset diabetes mellitus after transplantation (NODAT), infections requiring hospitalization, and requirement of anti-lipid medication at 12 months post-transplant.
- Avoidance of the requirement for maintenance corticosteroid therapy after renal transplantation.
- Allowance of reduced maintenance tacrolimus dosing (rTd).
- Conditions
- Transplant; Failure, Kidney
- Being tested
- Tacrolimus, Everolimus, Enteric Coated Mycophenolate Sodium (EC-MPS), Corticosteroids
- Keywords
- Kidney transplant patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf (brand name)
Tacrolimus dosing (rTd) is planned, 0.1 mg/kg PO BID - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml.
EverolimusDrug
Also called Zortress (brand name)
Everolimus initiated at 0.75 PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml.
Enteric Coated Mycophenolate Sodium (EC-MPS)Drug
Also called Myfortic (brand name)
EC-MPS 720 mg PO BID - beginning on 1st postoperative day.
CorticosteroidsDrug
Also called Methylprednisolone
Corticosteroids will be given as per our center protocol, i.e., a bolus of 500 mg of Methylprednisolone intravenously at surgery and daily x2, followed by 1.0 mg/kg, then 0.5 mg/kg orally until weaned off completely by 7-10 days postoperatively - the plan is for corticosteroids to be discontinued by 7-10 days postoperatively in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus and Everolimus | Experimental | Patients in both arms will receive reduced tacrolimus dosing (rTd), 0.1 mg/kg PO divided in two daily doses - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml.
Everolimus initiated within 24 hours post-transplant (i.e., immediately following randomization) at 0.75mg PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml. Receives: Drug: Tacrolimus; Drug: Everolimus; Drug: Corticosteroids |
| Tacrolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS) | Active comparator | Patients in both arms will receive reduced tacrolimus dosing (rTd), 0.1 mg/kg PO divided in two daily doses - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml.
EC-MPS will be initiated at 720 mg PO BID starting on the first post-operative day. Receives: Drug: Tacrolimus; Drug: Enteric Coated Mycophenolate Sodium (EC-MPS); Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant
BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.
Measured: 1 year
Secondary outcomes (6)
Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant
Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant.
Measured: 1 year
Graft Loss (Return to Permanent Dialysis or Death)
Measured: during the first 12 months post-transplant
eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.
using the abbreviated MDRD formula.
Measured: at 1 month post-transplant
eGFR (Renal Function) at Month 3 Post-transplant
Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula.
Measured: at 3 months post-transplant
eGFR (Renal Function) at 6 Months Post-transplant
using the abbreviated MDRD formula.
Measured: at 6 months post-transplant
Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)
Measured: during the first 12 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for Transplant; Failure, KidneyStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaetano Ciancio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gaetano Ciancio, University of Miami
- Investigators
- Gaetano Ciancio, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680861
- Sponsor's protocol ID
- 20110126
- Status last verified
- Oct 2016
- First submitted
- 6 Mar 2012
- Last updated
- 15 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label Trial of Tacrolimus/Everolimus vs. Tacrolimus/Enteric-Coated Mycophenolate Sodium to Prevent Biopsy-Proven Acute Rejection and Chronic Allograft Injury in Adult, Primary Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01680861
- Acronym / sponsor ID
- 20110126
- Conditions
- Transplant; Failure, Kidney
- Keywords
- Kidney transplant patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gaetano CiancioUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 15 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A recent therapeutic strategy following renal transplantation includes simultaneous use of reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic, antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to more favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal has also been used in the attempt to avoid well-known side effects while maintaining favorable patient and graft survival.8-10 While the investigators center and numerous other centers have also included single agent, antibody induction utilizing the lymphodepleting polyclonal antibody rabbit anti-human thymocyte globulin (ATG), nondepleting human anti-interleukin-2 receptor (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or lymphodepleting humanized anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now suggests that an even more effective induction strategy may include the combined use of more than one induction agent (each with fewer doses than if used alone), with the goal of bringing the kidney transplant recipient even closer (through more effectively timed lymphodepletion) to an optimally immunosuppressed state, allowing further reduction in long-term maintenance drug dosing.18-25 The investigators have now successfully used dual ATG/Dac induction therapy in both kidney-alone23-24 and simultaneous kidney-pancreas (SPK) transplantation,18-20 and a recent report from the investigators center of kidney-alone and SPK recipients shows that the addition of anti-CD25 to ATG for induction therapy more effectively delays the return of peripheral blood CD25+ cells.25 In the kidney-alone recipient study 3 doses of ATG were combined with 2 doses of Dac for induction,23-24 vs. the investigators previous studies utilizing single agent induction with 7 doses of ATG or 5 doses of Dac.4,16,17 Successful combination of ATG/basiliximab as dual induction in kidney transplantation has also been reported elsewhere,21-22 along with equivalency in clinical outcomes using daclizumab vs. basiliximab.13
Detailed description
- Primary Objectives:
- The percentage of patients who develop chronic allograft injury (CAI) progression during the first 12 months post-transplant protocol biopsy (i.e., higher grade of IF/TA at either the 6 or 12 month protocol biopsy in comparison with the baseline biopsy).
- The incidence rate of biopsy-proven acute rejection (BPAR) during the first 12 months post-transplant.
- Secondary Objectives:
- Adverse events including graft loss (death-censored and death-uncensored), and death at 12 months post-transplant.
- Incidence rate and severity (severity of CAI at 12 months as well), based upon careful review of all clinically indicated and protocol biopsies.
- Renal function as determined by serum creatinine and estimated glomerular filtration rate (eGFR) (calculated using the abbreviated MDRD formula) at 12, months post-transplant. Use of multivariable analysis to compare renal function as well as BPAR and CAI progression will also be performed (particularly, after adjusting for the significant effects of donor age, recipient age, race/ethnicity, and any other predictors).
- Adverse events including withholding (for ≥ 28 days) or discontinuance of study medications (and reasons why), new onset diabetes mellitus after transplantation (NODAT), infections requiring hospitalization, and requirement of anti-lipid medication at 12 months post-transplant.
- Avoidance of the requirement for maintenance corticosteroid therapy after renal transplantation.
- Allowance of reduced maintenance tacrolimus dosing (rTd).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus and Everolimus | Experimental | Drug: Tacrolimus, Drug: Everolimus, Drug: CorticosteroidsPatients in both arms will receive reduced tacrolimus dosing (rTd), 0.1 mg/kg PO divided in two daily doses - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml. Everolimus initiated within 24 hours post-transplant (i.e., immediately following randomization) at 0.75mg PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml. |
| Tacrolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS) | Active comparator | Drug: Tacrolimus, Drug: Enteric Coated Mycophenolate Sodium (EC-MPS), Drug: CorticosteroidsPatients in both arms will receive reduced tacrolimus dosing (rTd), 0.1 mg/kg PO divided in two daily doses - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml. EC-MPS will be initiated at 720 mg PO BID starting on the first post-operative day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Weight > 40 kg.
- Deceased donor (SCD) or LD.
- Donor-recipient 1 haplotype matched pairs with a minimum matching of 1 HLA DR antigen.
- Negative standard cross match for T cells.
- Pretransplant panel reactive antibodies of < 30%.
Key exclusion criteria (14 listed)
- Previously received or is receiving an organ transplant other than a kidney.
- Donor organ with a cold ischemic time > 48 hours.
- ABO incompatible donor kidney.
- Recipients of T cell, or B cell crossmatch positive transplant.
- Panel reactive antibody (PRA) >30%
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 |
|---|---|---|
| TacrolimusAlso: Prograf (brand name)Tacrolimus dosing (rTd) is planned, 0.1 mg/kg PO BID - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml. | Drug | Tacrolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS), Tacrolimus and Everolimus |
| EverolimusAlso: Zortress (brand name)Everolimus initiated at 0.75 PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml. | Drug | Tacrolimus and Everolimus |
| Enteric Coated Mycophenolate Sodium (EC-MPS)Also: Myfortic (brand name)EC-MPS 720 mg PO BID - beginning on 1st postoperative day. | Drug | Tacrolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS) |
| CorticosteroidsAlso: MethylprednisoloneCorticosteroids will be given as per our center protocol, i.e., a bolus of 500 mg of Methylprednisolone intravenously at surgery and daily x2, followed by 1.0 mg/kg, then 0.5 mg/kg orally until weaned off completely by 7-10 days postoperatively - the plan is for corticosteroids to be discontinued by 7-10 days postoperatively in both groups. | Drug | Tacrolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS), Tacrolimus and Everolimus |
Primary outcome
BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant
Time frame: 1 year
BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.
6 secondary outcomes
Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant
Time frame: 1 year
Graft Loss (Return to Permanent Dialysis or Death)
Time frame: during the first 12 months post-transplant
eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.
Time frame: at 1 month post-transplant
eGFR (Renal Function) at Month 3 Post-transplant
Time frame: at 3 months post-transplant
eGFR (Renal Function) at 6 Months Post-transplant
Time frame: at 6 months post-transplant
Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)
Time frame: during the first 12 months post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gaetano Ciancio, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus, Everolimus and Enteric Coated Mycophenolate Sodium (EC-MPS) in people with Transplant; Failure, Kidney, run by Gaetano Ciancio at 1 site in United States.
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 6 inclusion and 14 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 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 15 Dec 2016). 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?
BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2016.