Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Proteinuria Clinical Trial

Official title:

Consultant in Nephrology. MD., Ph.D.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694160
• Other study ID #: 2012/107 D
• Secondary ID: 2012-000429-32
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2012
• Last updated: March 29, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

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.

Description:

77 randomized, 37 paricalcitol, 40 no treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• kidney transplant patients

Exclusion Criteria:

• Previously transplanted

Study Design

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

Related Conditions & MeSH terms

• Proteinuria

Intervention

Drug:
• Paricalcitol
Zemplar (paricalcitol) 2ug daily, oral intake

Locations

Country	Name	City	State
Norway	Renal Section, Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in albumin/creatinine ratio from baseline to end of study.	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.	1 year	No