Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients

This study is currently recruiting participants.
Verified September 2012 by University Medical Centre Ljubljana
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Miha Arnol, M.D., Ph.D., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01436747
First received: September 14, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients' is designed to assess the effects of paricalcitol in kidney transplant recipients with proteinuria.

It is a single centre, randomized, placebo-controlled, double-blind clinical trial that tests the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will result in a decrease in urinary protein excretion in recipients of a kidney transplant at least three months after transplantation. Additionally, the effects of paricalcitol on albuminuria, estimated glomerular filtration rate, and blood pressure will be investigated.


Condition Intervention Phase
Disorder of Transplanted Kidney
Proteinuria
Albuminuria
Drug: Paricalcitol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Selective Vitamin D Receptor Activation With Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage change in urinary albumin to creatinine ratio (UACR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • The percentage change in 24-hour urinary protein excretion form baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • The proportion of patients achieving at least a 15% reduction in the last on-treatment UPCR level from the baseline. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in estimated glomerular filtration rate, blood pressure and biomarkers, including (but not limited to) C-reactive protein, plasma renin activity, aldosterone. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paricalcitol Drug: Paricalcitol
2 micrograms daily, peroral, 24 weeks
Other Name: Zemplar
Placebo Comparator: Matching placebo Drug: Placebo
2 micrograms daily, peroral, 24 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipients of a deceased donor kidney transplant at least 3 months after transplantation
  • Urinary protein to creatinine ratio (UPCR) > 200 mg/g (22 mg/mmol) as determined by the the mean of three second morning void urine specimens
  • Subject is on stable immunosuppression for at least 3 months
  • Subject is on stable doses of antihypertensive medications for at least 3 months
  • Subject is not expected to begin dialysis for at least 6 months
  • Estimated glomerular filtration rate > 15 ml/min/1.73 m2
  • Corrected serum calcium level <= 2.5 mmol/l
  • Intact parathormone value > 35 pg/ml

Exclusion Criteria:

  • Subjects on vitamin D receptor activation therapy within 3 months prior to the first study visit
  • Diagnosis of primary focal segmental glomerulosclerosis (FSGS)
  • Acute kidney injury within 3 months of the first study visit
  • Subjects with poorly controlled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436747

Contacts
Contact: Miha Arnol, M.D., Ph.D. +386 1 522 8977 miha.arnol@mf.uni-lj.si
Contact: Aljoša Kandus, M.D., Ph.D. +386 1 522 2978 aljosa.kandus@kclj.si

Locations
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Miha Arnol, M.D., Ph.D.    +386 1 522 8977    miha.arnol@mf.uni-lj.si   
Contact: Aljosa Kandus, M.D., Ph.D.    +386 1 522 2978    aljosa.kandus@kclj.si   
Principal Investigator: Miha Arnol, M.D., Ph.D.         
Sub-Investigator: Manca Oblak, M.D.         
Sub-Investigator: Gregor Mlinsek, M.D., Ph.D.         
Sub-Investigator: Jadranka Buturović-Ponikvar, M.D., Ph.D.         
Sub-Investigator: Aljosa Kandus, M.D., Ph.D.         
Sponsors and Collaborators
University Medical Centre Ljubljana
Abbott
Investigators
Principal Investigator: Miha Arnol, M.D., Ph.D. University Medical Centre Ljubljana, Department of Nephrology
Study Chair: Aljoša Kandus, M.D., Ph.D. University Medical Centre Ljubljana, Department of Nephrology
  More Information

No publications provided

Responsible Party: Miha Arnol, M.D., Ph.D., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01436747     History of Changes
Other Study ID Numbers: 31-06-2011
Study First Received: September 14, 2011
Last Updated: September 5, 2012
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Kidney transplantation
Proteinuria
Albuminuria
Vitamin D
Paricalcitol

Additional relevant MeSH terms:
Albuminuria
Proteinuria
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 April 15, 2014