Transplantation, LiverPhase 4NCT00178425
PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients
A Phase 4 study testing Serial blood sampling as described in protocol and Estimation of Creatinine Clearance at regular intervals in people with Transplantation, Liver, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Liver
- What is being tested?
- Serial blood sampling as described in protocol and Estimation of Creatinine Clearance at regular intervals
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 4
- 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
- Adult
- Female patients
- Negative pregnancy test
- Willing for contraception during the study period and 6 weeks after study
Who cannot join
- Serum Creatinine > 2.5 mg/dl
- On Dialysis
- HIV +ve
- Re-transplantation
- On Ventilator
- Multi-organ Transplant
- Platelets < 50,000
- WBC < 2,500
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Intravenous / Oral MMF and Oral Tacrolimus in Live Donor and Deceased Donor Liver Transplant Patients
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.
Read the detailed description
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.
12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study.
Each patient will have 12 (twelve) blood samples (half a teaspoon) drawn at 0,1, 2, 3, 4, 4½; 5, 6, 7, 8, 10 and 12 hours from an intravenous line placed during the operation. At the same time, 24-hour urine will be collected to measure your kidney function. After 4 to 6 days post transplant when the will be switched to oral MMF, again 10 (ten) blood samples a half teaspoon each will be drawn at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant. Total blood drawn over 3 months will be about 7 tablespoons. A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit (as a standard of care). The 24-hour urine will be collected at 1 and 3 months after transplant as well.
If a woman, who could become pregnant, a pregnancy test will be done before your transplant. They would also have to use birth control during the study period and 6 months after the completion of study.
- Conditions
- Transplantation, Liver
- Being tested
- Serial blood sampling as described in protocol, Estimation of Creatinine Clearance at regular intervals
- Keywords
- mycophenolate mofetil hydrochloride, pharmacokinetics, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial blood sampling as described in protocolProcedure or surgery
Estimation of Creatinine Clearance at regular intervalsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant
Secondary outcomes (2)
Comparison of Pharmacokinetics of IV MMF vs PO MMF
Pharmacokinetics of tacrolimus after liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, LiverStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Ashok Jain, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178425
- Sponsor's protocol ID
- RSRB 10410
- Other IDs
- CEL 458
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intravenous / Oral MMF and Oral Tacrolimus in Live Donor and Deceased Donor Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT00178425
- Acronym / sponsor ID
- RSRB 10410
- Conditions
- Transplantation, Liver
- Keywords
- mycophenolate mofetil hydrochloride, pharmacokinetics, tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jan 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.
Detailed description
The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.
12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study.
Each patient will have 12 (twelve) blood samples (half a teaspoon) drawn at 0,1, 2, 3, 4, 4½; 5, 6, 7, 8, 10 and 12 hours from an intravenous line placed during the operation. At the same time, 24-hour urine will be collected to measure your kidney function. After 4 to 6 days post transplant when the will be switched to oral MMF, again 10 (ten) blood samples a half teaspoon each will be drawn at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant. Total blood drawn over 3 months will be about 7 tablespoons. A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit (as a standard of care). The 24-hour urine will be collected at 1 and 3 months after transplant as well.
If a woman, who could become pregnant, a pregnancy test will be done before your transplant. They would also have to use birth control during the study period and 6 months after the completion of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult
- Female patients
- Negative pregnancy test
- Willing for contraception during the study period and 6 weeks after study
Key exclusion criteria (8 listed)
- Serum Creatinine > 2.5 mg/dl
- On Dialysis
- HIV +ve
- Re-transplantation
- On Ventilator
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 |
|---|---|---|
| Serial blood sampling as described in protocol | Procedure or surgery | – |
| Estimation of Creatinine Clearance at regular intervals | Procedure or surgery | – |
Primary outcome
Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant
2 secondary outcomes
Comparison of Pharmacokinetics of IV MMF vs PO MMF
Pharmacokinetics of tacrolimus after liver transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
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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.
Ashok Jain, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serial blood sampling as described in protocol and Estimation of Creatinine Clearance at regular intervals in people with Transplantation, Liver, run by University of Rochester 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 4 inclusion and 8 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 19 Apr 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of Pharmacokinetics of MMF in living donor liver transplant and deceased donor liver transplant. 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 19 Apr 2007.