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Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

This study is not yet open for participant recruitment.
Verified September 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Hallvard Holdaas, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01694160
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Proteinuria
 Drug: Paricalcitol
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consultant in Neprhology. MD. PhD.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Albumin exretion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol
Paricalcitol 2 ug/daily for 48 weeks
 Drug: Paricalcitol
Other Name: Zemplar
Placebo Comparator: Sugar pill
Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • kidney transplant patients

Exclusion Criteria:

  • Previously transplanted
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694160

Locations
Norway
Renal Section, Oslo University Hospital, Rikshospitalet Not yet recruiting
Oslo, Norway, 0424
Contact: Hallvard Holdaas, MD, PhD     4723071247     hallvard.holdaas@oslo-universitetssykehus.no    
Principal Investigator: Hallvard Holdaas, MD, PhD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Hallvard Holdaas, MD, PhD Oslo University Hospital, Rikshospitalet
  More Information

No publications provided

Responsible Party: Hallvard Holdaas, Consultant Nephrology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01694160     History of Changes
Other Study ID Numbers: 2012/107 D, 2012-000429-32
Study First Received: September 23, 2012
Last Updated: September 26, 2012
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
kidney transplant patients
Albuminuria

Additional relevant MeSH terms:
Proteinuria
Albuminuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ergocalciferols
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013