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Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Primary Purpose

Proteinuria

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring kidney transplant patients, Albuminuria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • kidney transplant patients

Exclusion Criteria:

  • Previously transplanted

Sites / Locations

  • Renal Section, Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Paricalcitol

no intervention

Arm Description

Paricalcitol 2 ug/daily for 48 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2012
Last Updated
March 29, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01694160
Brief Title
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
Official Title
Consultant in Nephrology. MD., Ph.D.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
kidney transplant patients, Albuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
Paricalcitol 2 ug/daily for 48 weeks
Arm Title
no intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Intervention Description
Zemplar (paricalcitol) 2ug daily, oral intake
Primary Outcome Measure Information:
Title
Change in albumin/creatinine ratio from baseline to end of study.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: kidney transplant patients Exclusion Criteria: Previously transplanted
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hallvard Holdaas, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal Section, Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Yes
Citations:
PubMed Identifier
33326471
Citation
Pihlstrom HK, Ueland T, Michelsen AE, Aukrust P, Gatti F, Hammarstrom C, Kasprzycka M, Wang J, Haraldsen G, Mjoen G, Dahle DO, Midtvedt K, Eide IA, Hartmann A, Holdaas H. Exploring the potential effect of paricalcitol on markers of inflammation in de novo renal transplant recipients. PLoS One. 2020 Dec 16;15(12):e0243759. doi: 10.1371/journal.pone.0243759. eCollection 2020.
Results Reference
derived
PubMed Identifier
30134956
Citation
Ussif A, Pihlstrom H, Pasch A, Holdaas H, Hartmann A, Smerud K, Asberg A. Paricalcitol supplementation during the first year after kidney transplantation does not affect calcification propensity score. BMC Nephrol. 2018 Aug 22;19(1):212. doi: 10.1186/s12882-018-1000-8.
Results Reference
derived

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Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

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