Liver TransplantationNCT00367146
MMF After Pediatric Liver Transplantation
A study testing MMF in people with Liver Transplantation and Chronic Kidney Disease, run by Hannover Medical School at 1 site in Germany.
Trial summary
The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Liver Transplantation, Chronic Kidney Disease
- What is being tested?
- MMF
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2004to Aug 2008
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients after pediatric liver transplantation
- no acute rejections for the last half year
Who cannot join
- concomitant malign disease (e.g. ptld)
- neutropenia (granulocytes <1000/µl)
- systemic infection
- thrombopenia (<80/nl)
Trial locations and contacts
1 site in 1 country.
About this study
The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.
The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.
- Conditions
- Liver Transplantation, Chronic Kidney Disease
- Being tested
- MMF
- Keywords
- liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
Measured: 1, 3, 6, 9, 12, 24 month
Secondary outcomes (3)
incidence of chronic kidney disease
Measured: 12, 24 month
incidence of infections
Measured: 1, 3, 6, 9, 12, 24 month
incidence of ptld (post transplant lymphoproliferative disease)
Measured: 1, 3, 6, 9, 12, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startNov 2004
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Michael Melter, PhD, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367146
- Sponsor's protocol ID
- MHH3474MMF
- Status last verified
- Jul 2007
- First submitted
- 21 Aug 2006
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMF After Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT00367146
- Acronym / sponsor ID
- MHH3474MMF
- Conditions
- Liver Transplantation, Chronic Kidney Disease
- Keywords
- liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Aug 2006 (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 use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.
The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients after pediatric liver transplantation
- no acute rejections for the last half year
Key exclusion criteria (4 listed)
- concomitant malign disease (e.g. ptld)
- neutropenia (granulocytes <1000/µl)
- systemic infection
- thrombopenia (<80/nl)
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 |
|---|---|---|
| MMF | Drug | – |
Primary outcome
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
Time frame: 1, 3, 6, 9, 12, 24 month
3 secondary outcomes
incidence of chronic kidney disease
Time frame: 12, 24 month
incidence of infections
Time frame: 1, 3, 6, 9, 12, 24 month
incidence of ptld (post transplant lymphoproliferative disease)
Time frame: 1, 3, 6, 9, 12, 24 month
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 20 May 2011.
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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.
Michael Melter, PhD, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMF in people with Liver Transplantation and Chronic Kidney Disease, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 4 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 20 May 2011. 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 Germany. 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?
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?
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections (time frame: 1, 3, 6, 9, 12, 24 month). 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 20 May 2011.