Liver TransplantationNCT00970073
Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
A study testing Thymoglobulin 3mg total, Thymoglobulin 4.5mg total and Mycophenolate mofetil in people with Liver Transplantation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Thymoglobulin 3mg total, Thymoglobulin 4.5mg total and Mycophenolate mofetil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2015
- Phase
- Interventional
- 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
- Patients undergoing deceased donor solitary liver transplantation
- Adults aged 18-70 at time of transplantation
- Hepatocellular carcinoma as indication for OLT within the Milan Criteria
- Hepatitis C positive or negative patients
- Willingness to comply with study procedures
- Able to sign informed consent
Who cannot join
- Prior kidney transplantation
- Congenital or iatrogenic absence of one kidney
- Subjects on renal replacement therapy at the time of OLT
- MELD score > 28
- HIV positive patient
- Patient with current severe systemic infection
Show all 11Show fewer
- History of bacterial peritonitis within 30 days prior to OLT
- Active infection or recent infection within 30 days prior to OLT
- Use of calcineurin inhibitor continuously for more than 90 days within the past 6 months
- History of hypersensitivity to thymoglobulin, rabbits, tacrolimus or iohexol
- Women of childbearing age who are unwilling to use effective contraceptive methods during the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic (Main Campus)
Cleveland, Ohio, 44195
About this study
Official title: A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
Read the detailed description
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
- Conditions
- Liver Transplantation
- Being tested
- Thymoglobulin 3mg total, Thymoglobulin 4.5mg total, Mycophenolate mofetil, tacrolimus 3-8, tacrolimus 8-12
- Keywords
- calcineurin inhibitor delay, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoglobulin 3mg totalBiological
1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Thymoglobulin 4.5mg totalBiological
1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Also called CellCept
1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8Drug
Also called Prograf
Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
tacrolimus 8-12Drug
Also called Prograf
Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
| Study group | Role | What they receive |
|---|---|---|
| Delayed CNI Group 1 | Experimental | Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) Receives: Biological: Thymoglobulin 3mg total; Drug: Mycophenolate mofetil; Drug: tacrolimus 3-8 |
| Delayed CNI Group 2 | Experimental | Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) Receives: Biological: Thymoglobulin 4.5mg total; Drug: Mycophenolate mofetil; Drug: tacrolimus 3-8 |
| Early CNI / Control Arm | Active comparator | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). Receives: Drug: Mycophenolate mofetil; Drug: tacrolimus 8-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
Measured: 12 Months
Secondary outcomes (3)
Patient Survival
Measured: 12 months post-transplant
Graft Survival
90% graft survival, related to the deaths of 3 patients during the study period.
Measured: 12 months post transplant
Allograft Rejection Rates at 30 Days
Acute Allograft Rejection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completion15 Jun 2015
- Study completionDec 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.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Bijan Eghtesad, MD, The Cleveland Clinic
- Investigators
- Bijan Eghtesad, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970073
- Sponsor's protocol ID
- CCIRB 09-432
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2009
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation
- ClinicalTrials.gov ID
- NCT00970073
- Acronym / sponsor ID
- CCIRB 09-432
- Conditions
- Liver Transplantation
- Keywords
- calcineurin inhibitor delay, Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Aug 2009 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
Detailed description
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed CNI Group 1 | Experimental | Biological: Thymoglobulin 3mg total, Drug: Mycophenolate mofetil, Drug: tacrolimus 3-8Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) |
| Delayed CNI Group 2 | Experimental | Biological: Thymoglobulin 4.5mg total, Drug: Mycophenolate mofetil, Drug: tacrolimus 3-8Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) |
| Early CNI / Control Arm | Active comparator | Drug: Mycophenolate mofetil, Drug: tacrolimus 8-12Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing deceased donor solitary liver transplantation
- Adults aged 18-70 at time of transplantation
- Hepatocellular carcinoma as indication for OLT within the Milan Criteria
- Hepatitis C positive or negative patients
- Willingness to comply with study procedures
Key exclusion criteria (11 listed)
- Prior kidney transplantation
- Congenital or iatrogenic absence of one kidney
- Subjects on renal replacement therapy at the time of OLT
- MELD score > 28
- HIV positive patient
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 |
|---|---|---|
| Thymoglobulin 3mg total1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) | Biological | Delayed CNI Group 1 |
| Thymoglobulin 4.5mg total1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) | Biological | Delayed CNI Group 2 |
| Mycophenolate mofetilAlso: CellCept1000 mg PO/IV BID for up to 6 months | Drug | Delayed CNI Group 1, Delayed CNI Group 2, Early CNI / Control Arm |
| tacrolimus 3-8Also: PrografTrough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 | Drug | Delayed CNI Group 1, Delayed CNI Group 2 |
| tacrolimus 8-12Also: PrografTrough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. | Drug | Early CNI / Control Arm |
Primary outcome
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
Time frame: 12 Months
Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
3 secondary outcomes
Patient Survival
Time frame: 12 months post-transplant
Graft Survival
Time frame: 12 months post transplant
Allograft Rejection Rates at 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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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.
Bijan Eghtesad, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymoglobulin 3mg total, Thymoglobulin 4.5mg total and Mycophenolate mofetil in people with Liver Transplantation, run by The Cleveland Clinic 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 11 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 9 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2018). 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?
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery (time frame: 12 Months). 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 9 Oct 2018.