No registrations found.
ID
Source
Brief title
Health condition
chronic kidney disease stages 3 and 4, defined by a eGFR of 15-60 ml min
Sponsors and support
Intervention
Outcome measures
Primary outcome
To 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 outcome
To assess differences in the innate immune system in patients with CKD before and after treatment with statins.
Background summary
This 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.
Study objective
To evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
Study design
3 months intevention
Intervention
Statin therapy will consist of a once daily dosis of 40 mg Atorvastatine for 3 months
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6717 |
| NTR-old | NTR6896 |
| Other | METC AMC : 2016_093 |