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Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

This study has been completed.
Information provided by (Responsible Party):
Hallvard Holdaas, Oslo University Hospital Identifier:
First received: September 23, 2012
Last updated: March 29, 2016
Last verified: March 2016
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 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Consultant in Nephrology. MD., Ph.D.

Resource links provided by NLM:

Further study details as provided by Hallvard Holdaas, Oslo University Hospital:

Primary Outcome Measures:
  • 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.

Enrollment: 77
Study Start Date: January 2013
Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol
Paricalcitol 2 ug/daily for 48 weeks
Drug: Paricalcitol
Zemplar (paricalcitol) 2ug daily, oral intake
No Intervention: no intervention

Detailed Description:
77 randomized, 37 paricalcitol, 40 no treatment

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • kidney transplant patients

Exclusion Criteria:

  • Previously transplanted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01694160

Renal Section, Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Hallvard Holdaas, MD, PhD Oslo University Hospital
  More Information

Responsible Party: Hallvard Holdaas, Consultant Nephrology, Oslo University Hospital Identifier: NCT01694160     History of Changes
Other Study ID Numbers: 2012/107 D
2012-000429-32 ( EudraCT Number )
Study First Received: September 23, 2012
Last Updated: March 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Yes

Keywords provided by Hallvard Holdaas, Oslo University Hospital:
kidney transplant patients

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017