NCT01694160

Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Consultant in Nephrology. MD., Ph.D.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

77 randomized, 37 paricalcitol, 40 no treatment

Conditions

• Proteinuria

Interventions

Type	Name	Description
DRUG	Paricalcitol	Zemplar (paricalcitol) 2ug daily, oral intake

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-01-01
• Completion: 2015-12-01
• First posted: 2012-09-27
• Last updated: 2016-03-30

Locations

1 site across 1 country: Norway