Transplant Trial Watch

Effects of paricalcitol on biomarkers of inflammation and fibrosis in kidney transplant recipients: results of a randomized controlled trial.

Oblak M, Mlinsek G, et al.

Clinical Nephrology 2017 Supplement 1; 88(13): 119-125.


Aims
To evaluate the effect of paricalcitol on renin-angiotensin system (RAS) activity, inflammation, and fibrosis in kidney transplant recipients.

Interventions
Participants were randomized to receive either placebo, or paricalcitol (2 μg/day). The study included an 8-week run-in phase followed by a 24-week randomized treatment period and an 8-week follow-up period after treatment withdrawal.

Participants
168 deceased-donor kidney transplant recipients aged ≥ 18 years old with estimated glomerular filtration rate ≥ 15 mL/min per 1.73m2 and urinary protein-to-creatinine ratio (UPCR) ≥ 20 mg/mmol.

Outcomes
The primary outcome measured was the percent change in geometric mean UPCR. Secondary outcomes included plasma renin activity and aldosterone concentration as biomarkers of RAS activity, as well as serum concentration of interleukin-6 as a biomarker of inflammation, and serum concentration of transforming growth factor as a biomarker of fibrosis.

Follow-up
8 weeks

CET Conclusions
This is a secondary analysis of a trial of paricalcitol versus placebo on proteinuria in kidney transplant patients. Now the authors have shown in these patients, all of whom had received either angiotensin converting enzyme blockers or angiotensin receptor blockers, a reduction in the proven inflammatory markers IL-6 and TGF-beta serum levels in the participants who received paricalcitol. There was also a significant reduction in systolic blood pressure in this group. Hence the authors suggest that administering paricalcitol for six months in transplanted patients would reduce the pro- inflammatory and pro-fibrotic markers, IL-6 and TGF-beta, which in turn may provide some renal protection and advantages for long-term kidney graft survival. This is certainly worthy of further study.

Jadad score
5

Data analysis
Available case analysis

Alocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT01436747 and EudraCT - 2011-006120-20

Funding source
Non-industry funded