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Efficacy of statin therapy on arterial wall inflammation in patients with Chronic Kidney Disease


- candidate number28325
- NTR NumberNTR6896
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2017
- Secondary IDs2016_093 METC AMC
- Public TitleEfficacy of statin therapy on arterial wall inflammation in patients with Chronic Kidney Disease
- Scientific TitleEfficacy of statin therapy on arterial wall inflammation in patients with Chronic Kidney Disease
- ACRONYMFLAME-CKD 2
- hypothesisTo evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
- Healt Condition(s) or Problem(s) studiedChronic renal failure, Statin
- Inclusion criteria1. Aged 50 years or older
2. CKD stages 3 and 4 (eGFR: 15-60 ml/min per 1.73m2)
3. Not receiving lipid lowering therapy
- Exclusion criteria1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Standard contra-indications to 18F-FDG PET, and CT based on physicians experience and current practices
3. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
4. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.
5. Clinical signs of acute infection and/or CRP>10
6. History of MI/Stroke or known coronary artery disease
7. Already receiving lipid lowering treatment
8. Treatment with dialysis or renal transplantation
9. Treatment with CYP3A4 inhibitors
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-nov-2016
- planned closingdate1-jul-2018
- Target number of participants17
- InterventionsStatin therapy will consist of a once daily dosis of 40 mg Atorvastatine for 3 months
- Primary outcomeTo evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
- Secondary outcomeTo assess differences in the innate immune system in patients with CKD before and after treatment with statins.
- Timepoints3 months intevention
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.M. Hoogeveen
- CONTACT for SCIENTIFIC QUERIES R.M. Hoogeveen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Unionís Horizon 2020 research and innovation programme, grant agreement No 667837
- Publications
- Brief summaryThis is a single centre intervention study. Our present study will consist of 17 patients with chronic kidney disease stages 3 and 4, defined by a eGFR of 15-60 ml min-1. The primary endpoint is the change in 18F-FDG target-to-background ratio (TBR) following 12 weeks of Atorvastatin 40 mg once daily.
- Main changes (audit trail)
- RECORD8-dec-2017 - 29-dec-2017


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