Liver TransplantPhase 3REDUCENCT02040584
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
A Phase 3 study testing Minimisation of TAC and TAC + MMF + corticosteroids in people with Liver Transplant, run by Novartis Pharmaceuticals at 20 sites in Spain.
Trial summary
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Minimisation of TAC and TAC + MMF + corticosteroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 20 sitesSpain
- Study dates
- 20 Dec 2013to 10 Feb 2016
- 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
Screening Visit - Inclusion Criteria
- Recipients age 18 or over receiving a first liver transplant from a cadaver donor.
- Patients diagnosed with HCC must meet the Milan radiological criteria at the time of transplant (1 nodule ≤5 cm in diameter, or 2-3 nodules, all <3 cm in diameter) - at time of patient's inclusion on the waiting list. Anh: done.
- Patients who have signed the informed consent to participate in the study.
- Patients who by medical criteria are capable of complying with the study regimen.
Screening Visit - Exclusion Criteria
- Recipients who have received multiple transplants of solid organs or pancreatic islet cells.
- Patients who have previously received an organ or tissue transplant.
- Patients with a combined liver-kidney transplant.
- Recipients of lobes or segments of liver from a live donor.
- A history of malignancy of any organ system in the previous 3 years according to local protocols (regardless of signs of local recurrence or metastasis), other than non-metastasising basal cell carcinoma or squamous cell carcinoma (epidermoid carcinoma) of the skin, or HCC.
- Patients with known hypersensitivity to the drugs used in the study or others of their class, or to any of their excipients.
- Recipients of ABO-incompatible transplants.
- Patients who test positive for HIV.
- Recipients of organs from donors who tested positive for the hepatitis B surface antigen or HIV seropositive.
- Patients with any medical or surgical condition that in the opinion of the investigator may significantly alter the absorption, distribution, metabolism or excretion of the study medication.
- Women of childbearing potential (i.e. women who are not postmenopausal with amenorrhoea of more than 1 year or surgically sterile) who are planning to become pregnant, are pregnant and/or breastfeeding, or who do not wish to use effective contraception, e.g. hormonal contraceptives (implantation, patches, oral) and double-barrier methods (any double combination of: IUD, male or female condoms with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).
- Patients who are taking part in another clinical trial.
Randomisation Visit - Inclusion Criteria
- Functioning allograft at the time of randomisation. A functioning allograft is defined as:
- levels of AST, ALT and total bilirubin ≤ 4 times the upper limit of normal, and
- levels of alkaline phosphatase and GGT ≤ 5 times the upper limit of normal.
- Glomerular filtrate ≥30 mL/min/1.73 m2 (calculated using the MDRD-4 equation).
Randomisation Visit - Exclusion Criteria
- Patients with proteinuria ≥1.0 g/24 hrs confirmed in the urine sample (protein/creatinine ratio) that cannot be explained by immediate post-operative causes.
- Patients with severe hypercholesterolaemia (≥350 mg/dL; ≥9 mmol/L) or severe hypertriglyceridaemia (≥750 mg/dL; ≥8.5 mmol/L).
- Patients with a platelet count ≤50,000/mm3.
- Patients with an absolute neutrophil count ≤1,000/mm3 or WBC count ≤2,000/mm3.
- Patients who cannot take oral medication.
- Patients with clinically significant systemic infection who require active use of intravenous antibiotics.
- Patients who are in intensive care units and require vital support measures such as mechanical ventilation, dialysis, or vasoactive drugs.
- Patients who have required renal replacement therapy in the 7 days prior to randomisation.
- Patients who have had an episode of acute rejection and have required antibody therapy or who have had more than one episode of corticosteroid-sensitive acute rejection.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Barakaldo, Basque Country, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
El Palmar, Murcia, 30120
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, 28007
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Valencia, Valencia, 46026
Novartis Investigative Site
Valladolid, Castille and León, 47012
Novartis Investigative Site
Zaragoza, 50009
About this study
Official title: A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients. The REDUCE Study.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF.
Read the detailed description
A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up.
- Conditions
- Liver Transplant
- Being tested
- Minimisation of TAC, TAC + MMF + corticosteroids
- Keywords
- De Novo Liver Transplant, Tacrolimus Minimisation, Everolimus, Renal Function, Liver transplant, allograft rejection, xenograft rejection, host vs graft disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimisation of TACDrug
•EVR: Treatment started at a total daily dose of 2 mg within 24 hours after randomisation. The dose of EVR was adjusted upon reaching trough levels (C-0h) in whole blood of 3-8 ng/mL. The daily dose (in two administrations) of EVR may have been modified to maintain trough levels (C-0h) in whole blood of 3-8 ng/mL until Week 52 post-transplant. •TAC: Once confirmation was obtained, beginning in Week 5, that trough levels (C-0h) in whole blood of EVR were between 3-8 ng/mL, minimisation of TAC began, in order to reach trough levels (C-0h) of TAC in whole blood of ≤5 ng/mL no later than four weeks after randomisation (Week 8), which were levels that should have been maintained until Week 52 post-transplant. •MMF was withdrawn at the same time that EVR was introduced. •oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted
TAC + MMF + corticosteroidsDrug
•Dose of TAC: Trough levels (C-0h) of TAC in whole blood should have been maintained between 6-10 ng/mL until Week 52 post-transplant. •Dose of MMF: Doses of 500-1000 mg/12 hrs was maintained until Week 52. •Corticosteroids: During the study, oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted (e.g. in patients with a history of HCV). It was recommended in any case that corticosteroids not be administered beyond Week 24 post-transplant except in cases of hepatopathy of autoimmune origin. At each centre all patients should have followed the same administration protocol for corticosteroids based on history of HCV.
| Study group | Role | What they receive |
|---|---|---|
| Minimisation of TAC | Experimental | Treatment with rTAC+EVR+corticosteroids Receives: Drug: Minimisation of TAC |
| TAC + MMF + corticosteroids | Active comparator | Treatment with TAC + MMF + corticosteroids Receives: Drug: TAC + MMF + corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Participants Showing Clinical Benefit by Renal Function Stratification
Clinical benefit is defined as: • an improvement in 1 or 2 ranges of the eGFR, according to MDRD-4 at Week 52 post-transplant in patients with values of 30-<45 or 45-<60 mL/min/1.73 m2 in Week 4. or • stabilisation of eGFR in patients with values ≥60 mL/min/1.73 m2 at Week 4 and maintained at Week 52 post-transplant.
Measured: week 4, week 52.
Secondary outcomes (10)
Changes in Creatinine Clearance - Cockcroft-Gault Formula
Kidney function was assessed over time by creatine clearance based on the Cockcroft-Gault formula.
Estimated creatinine clearance (mL/min) = [(140 - age) x (weight) x (0.85 if female)] / (72 x serum creatinine).
Units: age (years); weight (kg); serum creatinine (mg/dL). The values of the eGFR according to the creatinine clearance (Cockcroft-Gault formula) for the ITT population were ml/min/1.73 m^2.
Measured: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
Changes in eGFR Based on the MDRD-4 Formula
Kidney function was assessed over time by changes in eGFR according to the MDRD-4 formula. The MDRD-4 formula (Levey et al., 2000) was used based on serum concentration of creatinine (conventional units): eGFR (mL/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if of African descent).
Units: serum creatinine (mg/dL); age (years).
Measured: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
eGFR Values(MDRD-4 Formula) According to the MELD Score
Model for End Stage Liver Disease (MELD) score: ≤14, 15-19, 20-24, 25-29, ≥30. The higher the number indicates the urgency for transplant.
Measured: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
Urine Protein/Creatinine Ratio
The urine protein/creatinine ratio was assessed throughout follow-up in both treatment groups.
Measured: Screening visit, week 1,4,18,24, and 52
Percentage of Participants With Incidence of Proteinuria
The incidence of proteinuria (≥0.5-0.9 g/day, ≥1.0-2.9 g/day and ≥3.0 g/day) was assessed throughout follow-up in both treatment groups. Proteinuria was defined as protein/creatinine ratio ≥ 0.5.
Measured: Screening visit, week 1,4,18,24, and 52
Percentage of Participants With Acute Rejection, BPAR, and Treated BPAR
Liver biopsy had to be performed in all cases where acute rejection was suspected. Results of the biopsy were interpreted by the local pathologist (who did not known the treatment given to the patient) according to the Banff classification (1997).
Biopsy-proven acute rejection (BPAR) defined as clinical suspicion of acute rejection confirmed in biopsy.
Treated BPAR was deemed to be an episode of acute rejection in which the interpretation of the local pathologist showed that it reached any grade of acute rejection under the Banff classification, and for which anti-rejection therapy was administered.
Loss of the liver allograft was deemed to have occurred the day that the patient was again included on the waiting list for liver transplant, the day he or she received another allograft or upon the death of the patient.
All suspected hepatic allograft rejections were considered acute rejection
Measured: Throughout the study period, approximately 2 years and 2 months
Time to Rejection
Time to acute rejection was calculated from the date of transplantation. Acute rejection date was taken from biopsy date, as the date of rejection was not collected.
Time to treated BPAR was calculated from the date of transplantation.
Measured: Throughout study period, approximately 2 years and 2 months
Severity of Rejection
Severity of acute rejection and treated BPAR was graded according to Banff criteria.
Grade of acute rejection according to Banff criteria: mild, moderate, severe.
Measured: Throughout study period, approximately 2 years and 2 months
Percentages of Participants With HCV-positive and HCV Genotype
The viral load of HCV-RNA and HCV genotype was assessed in HCV-positive patients.
The term "genotype" was used to describe strains of HCV that vary but were related to the virus. Worldwide, there were 11 primary groups of HCV genotypes designated by the numbers from 1-11, with the most common in our setting being subtypes 1a, 1b, 2 and 3, which were identified in the local laboratory according to their usual testing methods.
Measured: approximately 2 years and 2 months
Concentration of p-P70S6K
the biomarker of personal response to everolimus, monitoring of the activity of the target, kinase P70 S6, in its phosphorylated form at Thr389.
EVR=everolimus Cmin=minimum concentration
Measured: weeks 6,8,12,18,24,36,52 at 0 (Cmin), and 1 (C1h) hrs post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start20 Dec 2013
- Primary completion10 Feb 2016
- Study completion10 Feb 2016
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 Liver TransplantStudies 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
- Model description
- A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up".
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040584
- Sponsor's protocol ID
- CRAD001HES01
- Other IDs
- 2013-001191-38
- Acronym
- REDUCE
- Status last verified
- Mar 2019
- First submitted
- 7 Jan 2014
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients. The REDUCE Study.
- ClinicalTrials.gov ID
- NCT02040584
- Acronym / sponsor ID
- REDUCE / CRAD001HES01
- Conditions
- Liver Transplant
- Keywords
- De Novo Liver Transplant, Tacrolimus Minimisation, Everolimus, Renal Function, Liver transplant, allograft rejection, xenograft rejection, host vs graft disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2013 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 10 Feb 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF.
Detailed description
A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up".
| Arm | Type | Receives |
|---|---|---|
| Minimisation of TAC | Experimental | Drug: Minimisation of TACTreatment with rTAC+EVR+corticosteroids |
| TAC + MMF + corticosteroids | Active comparator | Drug: TAC + MMF + corticosteroidsTreatment with TAC + MMF + corticosteroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Minimisation of TAC•EVR: Treatment started at a total daily dose of 2 mg within 24 hours after randomisation. The dose of EVR was adjusted upon reaching trough levels (C-0h) in whole blood of 3-8 ng/mL. The daily dose (in two administrations) of EVR may have been modified to maintain trough levels (C-0h) in whole blood of 3-8 ng/mL until Week 52 post-transplant. •TAC: Once confirmation was obtained, beginning in Week 5, that trough levels (C-0h) in whole blood of EVR were between 3-8 ng/mL, minimisation of TAC began, in order to reach trough levels (C-0h) of TAC in whole blood of ≤5 ng/mL no later than four weeks after randomisation (Week 8), which were levels that should have been maintained until Week 52 post-transplant. •MMF was withdrawn at the same time that EVR was introduced. •oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted | Drug | Minimisation of TAC |
| TAC + MMF + corticosteroids•Dose of TAC: Trough levels (C-0h) of TAC in whole blood should have been maintained between 6-10 ng/mL until Week 52 post-transplant. •Dose of MMF: Doses of 500-1000 mg/12 hrs was maintained until Week 52. •Corticosteroids: During the study, oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted (e.g. in patients with a history of HCV). It was recommended in any case that corticosteroids not be administered beyond Week 24 post-transplant except in cases of hepatopathy of autoimmune origin. At each centre all patients should have followed the same administration protocol for corticosteroids based on history of HCV. | Drug | TAC + MMF + corticosteroids |
Primary outcome
Percentages of Participants Showing Clinical Benefit by Renal Function Stratification
Time frame: week 4, week 52.
Clinical benefit is defined as: • an improvement in 1 or 2 ranges of the eGFR, according to MDRD-4 at Week 52 post-transplant in patients with values of 30-<45 or 45-<60 mL/min/1.73 m2 in Week 4. or • stabilisation of eGFR in patients with values ≥60 mL/min/1.73 m2 at Week 4 and maintained at Week 52 post-transplant.
10 secondary outcomes
Changes in Creatinine Clearance - Cockcroft-Gault Formula
Time frame: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
Changes in eGFR Based on the MDRD-4 Formula
Time frame: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
eGFR Values(MDRD-4 Formula) According to the MELD Score
Time frame: Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant
Urine Protein/Creatinine Ratio
Time frame: Screening visit, week 1,4,18,24, and 52
Percentage of Participants With Incidence of Proteinuria
Time frame: Screening visit, week 1,4,18,24, and 52
Percentage of Participants With Acute Rejection, BPAR, and Treated BPAR
Time frame: Throughout the study period, approximately 2 years and 2 months
Time to Rejection
Time frame: Throughout study period, approximately 2 years and 2 months
Severity of Rejection
Time frame: Throughout study period, approximately 2 years and 2 months
Percentages of Participants With HCV-positive and HCV Genotype
Time frame: approximately 2 years and 2 months
Concentration of p-P70S6K
Time frame: weeks 6,8,12,18,24,36,52 at 0 (Cmin), and 1 (C1h) hrs post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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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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
20 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 Minimisation of TAC and TAC + MMF + corticosteroids in people with Liver Transplant, run by Novartis Pharmaceuticals at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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 13 Jun 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?
Percentages of Participants Showing Clinical Benefit by Renal Function Stratification (time frame: week 4, week 52.). 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 13 Jun 2019.