Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694160
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Hallvard Holdaas, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Proteinuria Drug: Paricalcitol Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Consultant in Nephrology. MD., Ph.D.
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Paricalcitol
Paricalcitol 2 ug/daily for 48 weeks
Drug: Paricalcitol
Zemplar (paricalcitol) 2ug daily, oral intake

No Intervention: no intervention

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • kidney transplant patients

Exclusion Criteria:

  • Previously transplanted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 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