Kidney TransplantationNCT02808065
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
An observational study of Kidney Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Tacrolimus and Mycophenolate mofetil
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 kidney transplant recipients
Who may be able to join
- Age of 18 years or older
- At least 6 months after kidney transplantation
- Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
- Maintained stable dose of immunosuppressants for at least two weeks
Who cannot join
- AST or ALT >3 upper limit of normal range
- Had gastrointestinal disorder that may affect an absorption of drug
- Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
- Multi-organ transplant recipient
- Severe psychiatric disorder
- Drug or alcohol abuser
- Pregnant
- Low compliance
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jae Hyun Kim, 82-2-2072-0335, jaerung90@gmail.com
About this study
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.
Read the detailed description
Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus, Mycophenolate mofetil
- Keywords
- Kidney transplant, Kidney transplantation, Renal transplant, Renal transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf
Administered dose were individualized according to their own prescription
Also called Cellcept
Administered dose were individualized according to their own prescription
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus + Mycophenolate mofetil | Not described Receives: Drug: Tacrolimus; Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus concentration
Measured: 0, 1, 2, 3, 4 hours post-dose
Secondary outcomes (1)
Mycophenolate concentration
Measured: 0, 1, 2, 3, 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Principal investigator, Yon Su Kim, Seoul National University Hospital
- Investigators
- Yon Su Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808065
- Sponsor's protocol ID
- 17-2016-001-5
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02808065
- Acronym / sponsor ID
- 17-2016-001-5
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplant, Kidney transplantation, Renal transplant, Renal transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Jun 2016 (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.
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.
Detailed description
Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus + Mycophenolate mofetil | – | Drug: Tacrolimus, Drug: Mycophenolate mofetil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 kidney transplant recipients
Key inclusion criteria (4 listed)
- Age of 18 years or older
- At least 6 months after kidney transplantation
- Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
- Maintained stable dose of immunosuppressants for at least two weeks
Key exclusion criteria (8 listed)
- AST or ALT >3 upper limit of normal range
- Had gastrointestinal disorder that may affect an absorption of drug
- Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
- Multi-organ transplant recipient
- Severe psychiatric disorder
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 |
|---|---|---|
| TacrolimusAlso: PrografAdministered dose were individualized according to their own prescription | Drug | Tacrolimus + Mycophenolate mofetil |
| Mycophenolate mofetilAlso: CellceptAdministered dose were individualized according to their own prescription | Drug | Tacrolimus + Mycophenolate mofetil |
Primary outcome
Tacrolimus concentration
Time frame: 0, 1, 2, 3, 4 hours post-dose
1 secondary outcome
Mycophenolate concentration
Time frame: 0, 1, 2, 3, 4 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Related trials for Kidney Transplantation
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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Yon Su Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hyun Kim (82-2-2072-0335, jaerung90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tacrolimus concentration (time frame: 0, 1, 2, 3, 4 hours post-dose). 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 21 Jun 2016.