Function of Renal TransplantNCT00223054
Polymorphism of the Cytochrome P450-system in Renal Transplants
An observational study of Function of Renal Transplant, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Function of Renal Transplant
- What is being tested?
- tacrolimus, sirolimus and everolimus
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Oct 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patinets after kidney transplantation
Who may be able to join
- Renal transplant patients receiving one or more of the following drugs:
- tacrolimus
- sirolimus
- everolimus
- cyclosporin A
- fluvastatin
- Informed consent given by the patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, 24105
About this study
Official title: Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A
In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A).
All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.
Read the detailed description
Primary endpoint is the
- serum creatinine in patients with and without polymorphysms
- rate of rejections in patients with and without polymorphysms
- Conditions
- Function of Renal Transplant
- Being tested
- tacrolimus, sirolimus, everolimus, cyclosporin A
- Keywords
- cyclosporin A, Tacrolimus, Everolimus, Sirolimus, Fluvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
retrospective analyze of drug levels in comparison to polymorphism
sirolimusDrug
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
everolimusDrug
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
cyclosporin ADrug
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2006
- Study completionOct 2006
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 Function of Renal TransplantStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Investigators
- Lutz Renders, MD, Principal investigator, University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223054
- Sponsor's protocol ID
- 004
- Status last verified
- Jun 2008
- First submitted
- 14 Sep 2005
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Renders L, Frisman M, Ufer M, Mosyagin I, Haenisch S, Ott U, Caliebe A, Dechant M, Braun F, Kunzendorf U, Cascorbi I. CYP3A5 genotype markedly influences the pharmacokinetics of tacrolimus and sirolimus in kidney transplant recipients. Clin Pharmacol Ther. 2007 Feb;81(2):228-34. doi: 10.1038/sj.clpt.6100039. Epub 2006 Dec 27.
PubMed 17192769
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A
- ClinicalTrials.gov ID
- NCT00223054
- Acronym / sponsor ID
- 004
- Conditions
- Function of Renal Transplant
- Keywords
- cyclosporin A, Tacrolimus, Everolimus, Sirolimus, Fluvastatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- Mar 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 22 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.
In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A).
All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.
Detailed description
Primary endpoint is the
- serum creatinine in patients with and without polymorphysms
- rate of rejections in patients with and without polymorphysms
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patinets after kidney transplantation
Key inclusion criteria (7 listed)
- Renal transplant patients receiving one or more of the following drugs:
- Informed consent given by the patient
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tacrolimusretrospective analyze of drug levels in comparison to polymorphism | Drug | – |
| sirolimusretrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism | Drug | – |
| everolimusretrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism | Drug | – |
| cyclosporin Aretrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Aug 2011.
- Results publication: PubMed 17192769Renders L, Frisman M, Ufer M, Mosyagin I, Haenisch S, Ott U, Caliebe A, Dechant M, Braun F, Kunzendorf U, Cascorbi I. CYP3A5 genotype markedly influences the pharmacokinetics of tacrolimus and sirolimus in kidney transplant recipients. Clin Pharmacol Ther. 2007 Feb;81(2):228-34. doi: 10.1038/sj.clpt.6100039. Epub 2006 Dec 27.
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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.
Lutz Renders, MD principal investigator
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
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 Function of Renal Transplant, run by University Hospital Schleswig-Holstein 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 7 inclusion and 0 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 4 Aug 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00223054, 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 4 Aug 2011.