An interventional study of Paricalcitol in Fabry Disease and Proteinuria, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-18.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
Proteinuria is the predominant risk factor for renal disease progression in Fabry disease (FD). When urine protein excretion is controlled to \<0.50 g/24 hr, the rate loss of glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy. Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.
242 studies on the registry are indexed under Fabry Disease; 54 are open to participants now.
This study's enrollment of 14 is below the median of 22 across 105 interventional studies indexed under Fabry Disease.
Browse Fabry Disease studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
In patients identified by the inclusion criteria, data will be collected at baseline , during administration of oral Paricalcitol (PCT) (after 1, 3 and 6 months), and three months after PCT withdrawal. PCT will administered at dosage of 1 mcg/day; this dosage was chosen as it is not associated with excessive decline of parathyroid hormone (PTH) levels in most patients
Drug: Paricalcitol
Paricalcitol was administered at the dose of 1 mcg/die
Effect of paricalcitol on proteinuria reduction
Fourteen Fabry patients will be selected and studied in the first six months of add-on oral PCT (1 mcg/day) and, in order to verify the dependence of proteinuria reduction on PCT, three months after drug withdrawal.
Time frame: 6 months
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Federico II University