drugset / Trial / NCT01694160

Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

NCT01694160

Phase 3 Completed 77 enrolled Oslo University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

Timeline

Start
2013-01
Primary completion
2015-01
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Paricalcitol Other / unclassified 2 ug Oral

Indications