In stable renal transplant recipients with hyperparathyroidism, the vitamin D agonist paricalcitol reduces level of proteinuria. Animal studies indicate possible anti-fibrotic and anti-inflammatory effects. The early introduction of paricalcitol in de-novo renal transplant recipients might reduce proteinuria and prevent progressive allograft fibrosis.

We performed a single-centre, prospective, randomized, open-label trial investigating effects of paricalcitol 2[micro]g/day added to standard care. Participants were included 8 weeks after engraftment, and followed for 44 weeks. Primary endpoint was change in spot urine albumin/creatinine ratio. Exploratory microarray analyses of kidney biopsies at study end investigated potential effects on gene expression. Secondary endpoints included change in glomerular filtration rate (GFR), pulse wave velocity (PWV) and endothelial function measured by peripheral arterial tonometry as reactive hyperemia index (RHI).

Seventy-seven de-novo transplanted kidney allograft recipients were included, 37 receiving paricalcitol. Paricalcitol treatment lowered PTH-levels (p=0.01) but did not significantly reduce albuminuria (p=0.76), change vascular parameters (PWV; p=0.98, RHI; p=0.33) or influence GFR (p=0.57). Allograft gene expression was not significantly affected.

We conclude that in newly transplanted renal transplant recipients paricalcitol reduced PTH and was well tolerated without negative impact on kidney function. Paricalcitol did not significantly reduce/prevent albuminuria, improve parameters of vascular health or influence allograft gene expression. (ClinicalTrials.gov number NCT01694160 (2012/107D)).

CITATION INFORMATION: Pihlstrøm H, Gatti F, Hammarstrom C, Eide I, Kasprzycka M, Wang J, Haraldsen G, Svensson M, Midtvedt K, Hartmann A, Mjøen G, Dahle D, Holdaas H. Early Introduction of Oral Paricalcitol in Renal Transplant Recipients. An Open-Label Randomized Study. Am J Transplant. 2017;17 (suppl 3).

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