Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

University of Oslo (UIO)

Status and phase: Completed; Phase 3

Conditions: Proteinuria

Treatments: Drug: Paricalcitol

Study type: Interventional

Funder types: Other

Identifiers

NCT01694160

2012-000429-32 (EudraCT Number)

2012/107 D

Details and patient eligibility

About

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.

Full description

77 randomized, 37 paricalcitol, 40 no treatment

Enrollment: 77 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• kidney transplant patients

Exclusion criteria

• Previously transplanted

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 2 patient groups

Paricalcitol

Experimental group

Description:

Paricalcitol 2 ug/daily for 48 weeks

Treatment:

Drug: Paricalcitol

no intervention

No Intervention group