Renal TransplantationDDI-TACNCT00620841
Gene Polymorphisms in Tacrolimus Drug Interactions
An observational study of Renal Transplantation, run by KU Leuven at 1 site in Belgium.
Trial summary
A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- genotyping
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- May 2007to Jan 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal transplant recipients treated with a calcineurin-inhibitor
Who may be able to join
- Treatment with calcineurin-inhibitor
- Renal transplantation
Who cannot join
- Drug, alcohol addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients
A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients.
- Conditions
- Renal Transplantation
- Being tested
- genotyping
- Keywords
- Tacrolimus, Renal Transplantation, genetic polymorphisms, Drug drug interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotypingOther
Restriction fragment lenght polymorphisms
| Study group | Role | What they receive |
|---|---|---|
| A | Patients treated with tacrolimus and experiencing a drug interaction Receives: Other: genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus exposure parameters
Measured: weeks
Secondary outcomes (1)
Tacrolimus daily dosing
Measured: weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Investigators
- Dirk R Kuypers, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620841
- Sponsor's protocol ID
- DDI-001
- Acronym
- DDI-TAC
- Status last verified
- Jan 2008
- First submitted
- 13 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00620841
- Acronym / sponsor ID
- DDI-TAC / DDI-001
- Conditions
- Renal Transplantation
- Keywords
- Tacrolimus, Renal Transplantation, genetic polymorphisms, Drug drug interactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Feb 2008 (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.
A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: genotypingPatients treated with tacrolimus and experiencing a drug interaction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant recipients treated with a calcineurin-inhibitor
Key inclusion criteria (2 listed)
- Treatment with calcineurin-inhibitor
- Renal transplantation
Key exclusion criteria (1 listed)
- Drug, alcohol addiction
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 |
|---|---|---|
| genotypingRestriction fragment lenght polymorphisms | Other | A |
Primary outcome
Tacrolimus exposure parameters
Time frame: weeks
1 secondary outcome
Tacrolimus daily dosing
Time frame: weeks
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 22 Feb 2008.
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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.
Dirk R Kuypers, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Renal Transplantation, run by KU Leuven at 1 site in Belgium.
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 1 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 22 Feb 2008. 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 Belgium. 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?
Tacrolimus exposure parameters (time frame: weeks). 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 22 Feb 2008; AzTrials last refreshed its copy on 3 Nov 2026.