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

NCT01436747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2017-12-27

No results posted yet for this study

Summary

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.

Conditions

  • Disorder of Transplanted Kidney
  • Proteinuria
  • Albuminuria

Interventions

DRUG

Paricalcitol

2 micrograms daily, peroral, 24 weeks

DRUG

Placebo

2 micrograms daily, peroral, 24 weeks

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Miha Arnol, M.D., Ph.D. · University Medical Centre Ljubljana, Department of Nephrology

  • Aljoša Kandus, M.D., Ph.D. · University Medical Centre Ljubljana, Department of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-10-31
Completion
2015-07-31

Countries

  • Slovenia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436747 on ClinicalTrials.gov