Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Proteinuria Clinical Trial

Official title: Consultant in Nephrology. MD., Ph.D.

Status Completed

Clinical Trial 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.

Clinical Trial Description

77 randomized, 37 paricalcitol, 40 no treatment ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proteinuria

• NCT number: NCT01694160
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Completion date: December 2015