Renal TransplantationPhase 4NCT00223015
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
A Phase 4 study testing Fluvastatin, Tacrolimus, Mycophenolat Mofetil in people with Renal Transplantation, run by University Hospital Schleswig-Holstein.
Trial summary
Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs. All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Fluvastatin, Tacrolimus, Mycophenolat Mofetil
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Apr 2005
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal transplant patients (18 - 65 years, inclusive)
- cadaver and living renal transplants(1. Ntx, 2. Ntx)
- Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
- writen informt consent by the patient
Who cannot join
- contraindications for statins
- pregnancy or lactating
- elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)
About this study
Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.
All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included
- Conditions
- Renal Transplantation
- Being tested
- Fluvastatin, Tacrolimus, Mycophenolat Mofetil
- Keywords
- renal transplantation, pharmacokinetics, Fluvastatin, Mycophenolat mofetil, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluvastatin, Tacrolimus, Mycophenolat MofetilDrug
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 startMay 2004
- Study completionApr 2005
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Lutz Renders, MD, Principal investigator, University of Schleswig-Holstein, campus Kiel Department odf Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223015
- Sponsor's protocol ID
- 002
- Status last verified
- May 2004
- First submitted
- 14 Sep 2005
- Last updated
- 20 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
- ClinicalTrials.gov ID
- NCT00223015
- Acronym / sponsor ID
- 002
- Conditions
- Renal Transplantation
- Keywords
- renal transplantation, pharmacokinetics, Fluvastatin, Mycophenolat mofetil, tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Apr 2005
- 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.
Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.
All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- renal transplant patients (18 - 65 years, inclusive)
- cadaver and living renal transplants(1. Ntx, 2. Ntx)
- Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
- writen informt consent by the patient
Key exclusion criteria (3 listed)
- contraindications for statins
- pregnancy or lactating
- elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)
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 |
|---|---|---|
| Fluvastatin, Tacrolimus, Mycophenolat Mofetil | 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 20 Oct 2005.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
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
Kidney Transplant Recipient
Recruiting
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.
Lutz Renders, MD principal investigator
University of Schleswig-Holstein, campus Kiel Department odf Nephrology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluvastatin, Tacrolimus, Mycophenolat Mofetil in people with Renal Transplantation, run by University Hospital Schleswig-Holstein.
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 3 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 20 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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 20 Oct 2005.