Kidney TransplantNCT00281619
PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients
An observational study of Kidney Transplant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- CellCept (mycophenolate mofetil), Dietary Monitoring and Drug Diary
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2010
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Male subjects and non-pregnant female subjects aged 2-17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy, per clinical care.
Who may be able to join
- Male subjects and non-pregnant female subjects aged 2 to 17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy. Subjects may be enrolled up to their 18th year.
- Minimum weight of 11 kg.
- A signed and dated IRB approved parental / guardian informed consent form and an IRB-approved child assent form if applicable.
- A high probability for compliance with and completion of the study.
- For post-transplant study period: Subjects with stable kidney allografts who are at least 3 months post-transplant and who have received the same regimen of MMF (with cyclosporine or tacrolimus) for at least 30 days before the study visit (3-6 months post-transplant).
- May have clinically important abnormalities on clinical and /or laboratory evaluations only as these abnormalities relate to an underlying condition as determined by the principal investigator.
- Other variations from established normal ranges may be acceptable if they are not clinically significant in the opinion of the investigators.
Who cannot join
- Any medical condition (active or chronic) or prior surgery that may interfere with the pharmacokinetic behavior of MMF (absorption, distribution and elimination) as determined by the PI.
- Active systemic infection.
- History of substance abuse.
- Signs or symptoms of active hepatitis (a history of hepatitis B or C virus infection is permitted).
- Known history of or suspected infection with human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Development of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients
The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs.
Read the detailed description
This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney transplant, as well as during the stable renal transplant period when on a stable oral regimen of MPA. The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes.
- Conditions
- Kidney Transplant
- Being tested
- CellCept (mycophenolate mofetil), Dietary Monitoring, Drug Diary, Blood Sampling
- Keywords
- Pediatric Kidney Transplant, Kidney Transplant, CellCept, Mycophenolate mofetil, Mycophenolic Acid, MPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellCept (mycophenolate mofetil)Drug
Dietary MonitoringBehavioural
Drug DiaryBehavioural
Blood SamplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolic Acid (CellCept) | purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose Receives: Drug: CellCept (mycophenolate mofetil); Behavioral: Dietary Monitoring; Behavioral: Drug Diary; Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following outcome measures will be performed at study visit 2 (2-3 days post-transplant), study visit 3 (6-9 days post-transplant), and study visit 4 (3-6 months post-transplant):
Measured: 6 months
Drug Measurement of MPA and MPA-G
Measured: 6 months
IMPDH Assay
Measured: 6 months
Mitogenesis Assays and
Measured: 6 months
Determination of CD25 Expression.
Measured: 6 months
Secondary outcomes (5)
Concomitant medications and MPA (CellCept) drug diary (study visits 1-4)
Measured: 6 months
Physical Exam (study visits 1-4)
Measured: 6 months
Safety Laboratory tests (study visits 1-4)
Measured: 6 months
Dietary Monitoring (study visits 2,3 & 4)
Measured: 6 months
Adverse Event Reporting (study visits 1-4).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Alexander A. Vinks, PharmD., PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281619
- Sponsor's protocol ID
- CEL420 MPA (PK-PD)
- Other IDs
- CEL420
- Status last verified
- Dec 2013
- First submitted
- 23 Jan 2006
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT00281619
- Acronym / sponsor ID
- CEL420 MPA (PK-PD)
- Conditions
- Kidney Transplant
- Keywords
- Pediatric Kidney Transplant, Kidney Transplant, CellCept, Mycophenolate mofetil, Mycophenolic Acid, MPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jan 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Jan 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 purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs.
Detailed description
This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney transplant, as well as during the stable renal transplant period when on a stable oral regimen of MPA. The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycophenolic Acid (CellCept) | – | Drug: CellCept (mycophenolate mofetil), Behavioral: Dietary Monitoring, Behavioral: Drug Diary, Procedure: Blood Samplingpurpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male subjects and non-pregnant female subjects aged 2-17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy, per clinical care.
Key inclusion criteria (7 listed)
- Male subjects and non-pregnant female subjects aged 2 to 17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy. Subjects may be enrolled up to their 18th year.
- Minimum weight of 11 kg.
- A signed and dated IRB approved parental / guardian informed consent form and an IRB-approved child assent form if applicable.
- A high probability for compliance with and completion of the study.
- For post-transplant study period: Subjects with stable kidney allografts who are at least 3 months post-transplant and who have received the same regimen of MMF (with cyclosporine or tacrolimus) for at least 30 days before the study visit (3-6 months post-transplant).
Key exclusion criteria (5 listed)
- Any medical condition (active or chronic) or prior surgery that may interfere with the pharmacokinetic behavior of MMF (absorption, distribution and elimination) as determined by the PI.
- Active systemic infection.
- History of substance abuse.
- Signs or symptoms of active hepatitis (a history of hepatitis B or C virus infection is permitted).
- Known history of or suspected infection with human immunodeficiency virus (HIV).
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 |
|---|---|---|
| CellCept (mycophenolate mofetil) | Drug | Mycophenolic Acid (CellCept) |
| Dietary Monitoring | Behavioural | Mycophenolic Acid (CellCept) |
| Drug Diary | Behavioural | Mycophenolic Acid (CellCept) |
| Blood Sampling | Procedure or surgery | Mycophenolic Acid (CellCept) |
Primary outcome
The following outcome measures will be performed at study visit 2 (2-3 days post-transplant), study visit 3 (6-9 days post-transplant), and study visit 4 (3-6 months post-transplant):
Time frame: 6 months
Drug Measurement of MPA and MPA-G
Time frame: 6 months
IMPDH Assay
Time frame: 6 months
Mitogenesis Assays and
Time frame: 6 months
Determination of CD25 Expression.
Time frame: 6 months
5 secondary outcomes
Concomitant medications and MPA (CellCept) drug diary (study visits 1-4)
Time frame: 6 months
Physical Exam (study visits 1-4)
Time frame: 6 months
Safety Laboratory tests (study visits 1-4)
Time frame: 6 months
Dietary Monitoring (study visits 2,3 & 4)
Time frame: 6 months
Adverse Event Reporting (study visits 1-4).
Time frame: 6 months
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 Dec 2013.
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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.
Alexander A. Vinks, PharmD., PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by Children's Hospital Medical Center, Cincinnati 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 7 inclusion and 5 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 Dec 2013. 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?
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?
The following outcome measures will be performed at study visit 2 (2-3 days post-transplant), study visit 3 (6-9 days post-transplant), and study visit 4 (3-6 months post-transplant): (time frame: 6 months). The study lists 5 primary outcomes in all. 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 Dec 2013.