- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01694160
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
March 29, 2016 updated by: Hallvard Holdaas, Oslo University Hospital
Consultant in Nephrology. MD., Ph.D.
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.
Study Overview
Detailed Description
77 randomized, 37 paricalcitol, 40 no treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway, 0424
- Renal Section, Oslo University Hospital, Rikshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- kidney transplant patients
Exclusion Criteria:
- Previously transplanted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: no intervention
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Experimental: Paricalcitol
Paricalcitol 2 ug/daily for 48 weeks
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Zemplar (paricalcitol) 2ug daily, oral intake
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in albumin/creatinine ratio from baseline to end of study.
Time Frame: 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.
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hallvard Holdaas, MD, PhD, Oslo University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 23, 2012
First Submitted That Met QC Criteria
September 26, 2012
First Posted (Estimate)
September 27, 2012
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 29, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/107 D
- 2012-000429-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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