Kidney TransplantationPhase 4NCT00166829
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
A Phase 4 study testing sirolimus, tacrolimus, mycophenolate mofetil in people with Kidney Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- sirolimus, tacrolimus, mycophenolate mofetil
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2004to not given
- 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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- De novo kidney transplant patients
- Aged 13 - 65 years
- Having aminotransferase concentrations within 2 times the upper limit of normal
Who cannot join
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multi-organ transplantation
- History of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Meng-Kun Tsai, MD, PhD, 886-2-23123456 ext. 5622, mark9@ha.mc.ntu.edu.tw
Fe-Lin L Wu, PhD, 886-2-23123456 ext. 8389, flwu@ha.mc.ntu.edu.tw
About this study
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Read the detailed description
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
- Conditions
- Kidney Transplantation
- Being tested
- sirolimus, tacrolimus, mycophenolate mofetil
- Keywords
- Tacrolimus, Sirolimus, Mycophenolic acid, Immunosuppressive Agents, Immunosuppression, Kidney Transplantation, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus, tacrolimus, mycophenolate mofetilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
Secondary outcomes (1)
Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Po-Huang Lee, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166829
- Sponsor's protocol ID
- 920606
- Status last verified
- Aug 2003
- First submitted
- 12 Sep 2005
- Last updated
- 8 Mar 2007
- Results posted
- No
Publications
Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608.
PubMed 19670189
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
- ClinicalTrials.gov ID
- NCT00166829
- Acronym / sponsor ID
- 920606
- Conditions
- Kidney Transplantation
- Keywords
- Tacrolimus, Sirolimus, Mycophenolic acid, Immunosuppressive Agents, Immunosuppression, Kidney Transplantation, Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2004
- First posted
- 14 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 understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Detailed description
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- De novo kidney transplant patients
- Aged 13 - 65 years
- Having aminotransferase concentrations within 2 times the upper limit of normal
Key exclusion criteria (6 listed)
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multi-organ transplantation
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 |
|---|---|---|
| sirolimus, tacrolimus, mycophenolate mofetil | Drug | – |
Primary outcome
The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
1 secondary outcome
Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2007.
- Derived from this study: PubMed 19670189Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608.
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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.
Po-Huang Lee, MD, PhD study chair
National Taiwan University Hospital
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 sirolimus, tacrolimus, mycophenolate mofetil in people with Kidney Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 6 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 8 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Kun Tsai, MD, PhD (886-2-23123456 ext. 5622, mark9@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166829, which also lists 1 linked publication.
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 8 Mar 2007.