Renal TransplantationPhase 2/3NCT00223041
Cranoc Lipid Study in Renal Transplantation
A Phase 2/3 study testing Fluvastatin in people with Renal Transplantation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2003to Dec 2010
- Phase
- Phase 2/3
- 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
- patients (18 - 65, inclusive)
- cadaver and living kidney transplantation (1. Ntx, 2. Ntx)
- LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
- Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
- Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
- patients indulgence
Who cannot join
- statin before the study
- LDL-Cholesterol >130mg/dl before transplantation
- Instabil Angina, Myocard infarct <6 months before transplantation
- symptomatic Hypothyreosis
- child bearing, lactating
- elavated liver encymes (> 2x elavated: AST, ALT, bilirubine, PCK)
- Fibrates are not allowed
- multiorgantransplantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, 24251
About this study
Official title: Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
Read the detailed description
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
- Conditions
- Renal Transplantation
- Being tested
- Fluvastatin
- Keywords
- renal transplantation, cardiovasculary disease, statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Arm A receives fluvastatin Arm b receives no fluvastatin
| Study group | Role | What they receive |
|---|---|---|
| A (therapy with fluvastatin 80mg retard) | No intervention | kidney transplants receive in addition fluvastatin 80mg retard for 3 years |
| B | Placebo comparator | no therapy with fluvastatin Receives: Drug: Fluvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
Measured: during the study
Secondary outcomes (4)
patients and kidney survival
Measured: during the study
amount and typ of rejection (Banff-classifikation)
Measured: during the study
change in lipids
Measured: during the study
adverse events of the statin fluvastatin
Measured: during the study
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 startApr 2003
- Primary completionNov 2009
- Study completionDec 2010
Why it stopped: No possibilty to receive all plened patients for this study
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Lutz Renders, MD, Principal investigator, University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223041
- Sponsor's protocol ID
- 001
- Status last verified
- May 2006
- First submitted
- 14 Sep 2005
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin
- ClinicalTrials.gov ID
- NCT00223041
- Acronym / sponsor ID
- 001
- Conditions
- Renal Transplantation
- Keywords
- renal transplantation, cardiovasculary disease, statin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No possibilty to receive all plened patients for this study
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (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.
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
Detailed description
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (therapy with fluvastatin 80mg retard) | No intervention | –kidney transplants receive in addition fluvastatin 80mg retard for 3 years |
| B | Placebo comparator | Drug: Fluvastatinno therapy with fluvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients (18 - 65, inclusive)
- cadaver and living kidney transplantation (1. Ntx, 2. Ntx)
- LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
- Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
- Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
Key exclusion criteria (8 listed)
- statin before the study
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 |
|---|---|---|
| FluvastatinArm A receives fluvastatin Arm b receives no fluvastatin | Drug | B |
Primary outcome
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
Time frame: during the study
4 secondary outcomes
patients and kidney survival
Time frame: during the study
amount and typ of rejection (Banff-classifikation)
Time frame: during the study
change in lipids
Time frame: during the study
adverse events of the statin fluvastatin
Time frame: during the study
Results and safety
The study was stopped early (reason given: No possibilty to receive all plened patients for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
Related trials for Renal Transplantation
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
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 Scghleswig-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?
A Phase 2/3 study testing Fluvastatin in people with Renal Transplantation, 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 6 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: stopped early, as of the sponsor's last update on 8 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: No possibilty to receive all plened patients for this study). Results are not available in the source record.
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?
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) (time frame: during the study). 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 8 Aug 2011.