Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Phase 3

Completed

• Conditions: Proteinuria
• Interventions: Drug: Paricalcitol

• Registration Number: NCT01694160
• Lead Sponsor: Oslo University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Study Start: 2013-01
• Primary Completion: 2015-01
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• kidney transplant patients

Exclusion Criteria

• Previously transplanted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paricalcitol	Paricalcitol	Paricalcitol 2 ug/daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
Change in albumin/creatinine ratio from baseline to end of study.	1 year	Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5.

Trial Locations

Locations (1)

Renal Section, Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway