Graft VasculopathyPhase 4NCT00565474
Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant
A Phase 4 study testing Fluvastatin in people with Graft Vasculopathy, run by Novartis Pharmaceuticals at 1 site in Spain.
Trial summary
Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graft Vasculopathy
- What is being tested?
- Fluvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2001to Oct 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients where the investigator expects to prescribe cyclosporine, mycophenolate mofetil and corticosteroids as base immunosuppressive therapy, regardless of their participation in the study.
- Man or woman aged from 17 to 70 years.
- Patients that receive a first or second renal transplant from a non-living donor
- Patients where allograft biopsies may be performed.
- Patients receiving an identical or compatible ABO graft.
- Patients willing to give their written informed consent to all study issues.
- Women with child-bearing potential should use a medically proven contraceptive method during the study.
- Patients able to meet all study requirements.
Who cannot join
- Patients with pre-transplant cholesterol levels above 240 mg/dl (6.2 mmol/l).
- Positive cross-match of T cells or ABO incompatibility with the donor.
- Recipients of multiorgan transplant.
- Patients with diabetes mellitus.
- HIV seropositive or with surface antigen of Hepatitis B .
- Kidney from a donor aged over 65 years.
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- Last panel of reactive antibody (PRA) above 50%.
- Women who plan to get pregnant within 12 months, or who are pregnant and/or nursing.
- Patients with a history of cancer in the previous 5 years, except for patients successfully treated with localized carcinoma of squamous or basal cells of the skin, or cervix cancer in situ treated adequately.
- Patients receiving an investigational drug in the 30 days prior to the transplant and/or who will receive an investigational/non-registered drug during the study, except for the use of erythropoietin-stimulating products
- Patients with myocardial infarction within the 6 months prior to the transplant, uncontrollable cardiac arrhythmia or another severe or unstable medical condition probably affecting the safety of the patient or the study objectives.
- Patients with alcohol dependence or drug abuse not solved, or signs of organic lesion caused by alcohol, mental dysfunction or other factors limiting their ability to fully cooperate with the study.
- Patients where it is planned to perform an induction treatment with preparations containing antilymphocyte antibodies (ALG, ATG or OKT-3).
- Patients scheduled to receive cyclosporine i.v. for over 48 hours.
- Patients with liver dysfunction (ALT or AST values or total bilirubin 2 times above the upper limit of the normal ranges of the laboratory values).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled, 6-month Study to Establish the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vascular Graft Disease in de Novo Renal Transplant Patients
Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients.
- Conditions
- Graft Vasculopathy
- Being tested
- Fluvastatin
- Keywords
- Renal transplantation, fluvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Graft vasculopathy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fluvastatin 40mg b.i.d. Receives: Drug: Fluvastatin |
| 2 | Placebo comparator | Placebo b.i.d. Receives: Drug: Fluvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if treatment with fluvastatin can prevent the progression of vascular graft disease. The difference between the vascular intimal thickness measured on the baseline biopsy and the biopsy at the end of the study between the two treatment group
Measured: three Yrs
Secondary outcomes (1)
24-hour creatinine and proteinuria values at 6 months post-transplant, graft survival and patient survival at 6 months, differences in lipid profile between the treatment groups, incidence of rejection episodes treated and documented by biopsy at 6
Measured: Three yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startSep 2001
- Primary completionOct 2007
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 Graft VasculopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Double blind
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565474
- Sponsor's protocol ID
- LESTX-ES-01
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2007
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Seron D, Oppenheimer F, Pallardo LM, Lauzurica R, Errasti P, Gomez-Huertas E, Bosmans JL, Sanchez-Plumed J, Romero R, Marques M, Fulladosa X, Moreso F. Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial. Transplantation. 2008 Jul 15;86(1):82-7. doi: 10.1097/TP.0b013e318174428d.
PubMed 18622282
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled, 6-month Study to Establish the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vascular Graft Disease in de Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00565474
- Acronym / sponsor ID
- LESTX-ES-01
- Conditions
- Graft Vasculopathy
- Keywords
- Renal transplantation, fluvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Oct 2007 (actual)
- First posted
- 30 Nov 2007 (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.
Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fluvastatinfluvastatin 40mg b.i.d. |
| 2 | Placebo comparator | Drug: FluvastatinPlacebo b.i.d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients where the investigator expects to prescribe cyclosporine, mycophenolate mofetil and corticosteroids as base immunosuppressive therapy, regardless of their participation in the study.
- Man or woman aged from 17 to 70 years.
- Patients that receive a first or second renal transplant from a non-living donor
- Patients where allograft biopsies may be performed.
- Patients receiving an identical or compatible ABO graft.
Key exclusion criteria (16 listed)
- Patients with pre-transplant cholesterol levels above 240 mg/dl (6.2 mmol/l).
- Positive cross-match of T cells or ABO incompatibility with the donor.
- Recipients of multiorgan transplant.
- Patients with diabetes mellitus.
- HIV seropositive or with surface antigen of Hepatitis B .
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 |
|---|---|---|
| FluvastatinGraft vasculopathy | Drug | 1, 2 |
Primary outcome
To determine if treatment with fluvastatin can prevent the progression of vascular graft disease. The difference between the vascular intimal thickness measured on the baseline biopsy and the biopsy at the end of the study between the two treatment group
Time frame: three Yrs
1 secondary outcome
24-hour creatinine and proteinuria values at 6 months post-transplant, graft survival and patient survival at 6 months, differences in lipid profile between the treatment groups, incidence of rejection episodes treated and documented by biopsy at 6
Time frame: Three yrs
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 23 Feb 2017.
- Results publication: PubMed 18622282Seron D, Oppenheimer F, Pallardo LM, Lauzurica R, Errasti P, Gomez-Huertas E, Bosmans JL, Sanchez-Plumed J, Romero R, Marques M, Fulladosa X, Moreso F. Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial. Transplantation. 2008 Jul 15;86(1):82-7. doi: 10.1097/TP.0b013e318174428d.
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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.
Novartis study director
Novartis
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 Fluvastatin in people with Graft Vasculopathy, run by Novartis Pharmaceuticals at 1 site in Spain.
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 8 inclusion and 16 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 23 Feb 2017. 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 Spain. 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 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.
What does the primary outcome measure?
To determine if treatment with fluvastatin can prevent the progression of vascular graft disease. The difference between the vascular intimal thickness measured on the baseline biopsy and the biopsy at the end of the study between the two treatment group (time frame: three Yrs). 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 NCT00565474, 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 23 Feb 2017.