Liver TransplantationPhase 3PrometheusNCT03596970
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
A Phase 3 study testing TAC withdrawal and Everolimus with reduced TAC in people with Liver Transplantation, run by Novartis Pharmaceuticals.
Trial summary
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- TAC withdrawal and Everolimus with reduced TAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients willing and capable of providing written informed consent for study participation.
- Adults 18 to 70 years of age.
- Liver allograft from a deceased or living donor.
- Treated with a CNI containing immunosuppressive regimen.
- Liver transplant 6 to 24 months prior to screening.
- Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.
- Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).
Who cannot join
- Multiple solid organ transplant recipients
- Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
- Malignant diseases other than neoplasms of the skin.
- Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
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- Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
- HIV positivity
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)
- Conditions
- Liver Transplantation
- Being tested
- TAC withdrawal, Everolimus with reduced TAC
- Keywords
- Open-label, randomized, calcineurin-inhibitor, CNI, tacrolimus, MMF, maintenance liver transplant, RAD001H, CRAD001H, liver transplant, transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAC withdrawalDrug
Everolimus (RAD001) with MMF and Steroids
Everolimus with reduced TACDrug
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids
| Study group | Role | What they receive |
|---|---|---|
| Everolimus with MMF (TAC-withdrawal) | Experimental | Everolimus (RAD001) with MMF and Steroids Receives: Drug: TAC withdrawal |
| Everolimus with reduced TAC | Active comparator | Everolimus (RAD001) with reduced TAC and Steroids Receives: Drug: Everolimus with reduced TAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function
The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.
Measured: Randomization to Month 6
Secondary outcomes (1)
Efficacy (tBPAR, graft loss, death, loss to follow-up)
Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date.
Measured: To Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study startSep 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596970
- Sponsor's protocol ID
- CRAD001HDE53
- Acronym
- Prometheus
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2015
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)
- ClinicalTrials.gov ID
- NCT03596970
- Acronym / sponsor ID
- Prometheus / CRAD001HDE53
- Conditions
- Liver Transplantation
- Keywords
- Open-label, randomized, calcineurin-inhibitor, CNI, tacrolimus, MMF, maintenance liver transplant, RAD001H
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus with MMF (TAC-withdrawal) | Experimental | Drug: TAC withdrawalEverolimus (RAD001) with MMF and Steroids |
| Everolimus with reduced TAC | Active comparator | Drug: Everolimus with reduced TACEverolimus (RAD001) with reduced TAC and Steroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients willing and capable of providing written informed consent for study participation.
- Adults 18 to 70 years of age.
- Liver allograft from a deceased or living donor.
- Treated with a CNI containing immunosuppressive regimen.
- Liver transplant 6 to 24 months prior to screening.
Key exclusion criteria (9 listed)
- Multiple solid organ transplant recipients
- Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
- Malignant diseases other than neoplasms of the skin.
- Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| TAC withdrawalEverolimus (RAD001) with MMF and Steroids | Drug | Everolimus with MMF (TAC-withdrawal) |
| Everolimus with reduced TACActive comparator arm: Everolimus (RAD001) with reduced TAC and Steroids | Drug | Everolimus with reduced TAC |
Primary outcome
Renal Function
Time frame: Randomization to Month 6
The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.
1 secondary outcome
Efficacy (tBPAR, graft loss, death, loss to follow-up)
Time frame: To Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAC withdrawal and Everolimus with reduced TAC in people with Liver Transplantation, run by Novartis Pharmaceuticals.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Renal Function (time frame: Randomization to Month 6). 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 24 Jul 2018.