Skip to content

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

Efficacy of statin therapy on arterial wall inflammation in patients with Chronic Kidney Disease - FLAME-CKD 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45991
Enrollment
17
Registered
2016-09-08
Start date
2016-11-10
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arterial wall thickening atherosclerosis

Interventions

3 months treatment with atorvastatin 40 mg 1 tablet daily

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 years or older 2. CKD stages 3 and 4 (eGFR: 15-60 ml min-1)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in target-to-background ratio (TBR) in patients with CKD before and after statin therapy

Secondary

MeasureTime frame
- Monocyte subtyping will be assessed by FACS analysis - Monocyte expression of genes involved in inflammation - Trans endothelial migration will be assessed according to standard procedures at Sanquin as described in van Buul et al (16). - In vitro cytokine production will be assessed using isolated monocytes of subjects. Monocytes will be stimulized with LPS, assessing production of inflammatory cytokines (Il6, TNF*) - Epigenetic changes will be assessed by looking at H3K4 methylation at target genes assessed in the previous steps.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)