NCT01436747

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

September 14, 2011

Last Update Submit

December 22, 2017

Conditions

Disorder of Transplanted KidneyProteinuriaAlbuminuria

Keywords

Kidney transplantationProteinuriaAlbuminuriaVitamin DParicalcitol

Outcome Measures

Primary Outcomes (1)

  • The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment.

    baseline and 6 months

Secondary Outcomes (4)

  • The percentage change in urinary albumin to creatinine ratio (UACR) from baseline to the last measurement during treatment.

    baseline and 6 months

  • Change in 24-hour urinary protein excretion form baseline to the last measurement during treatment.

    baseline and 6 months

  • The proportion of patients achieving at least a 15 mg/mmol reduction in the last on-treatment UPCR level from the baseline.

    baseline and 6 months

  • Change in estimated glomerular filtration rate, blood pressure and biomarkers, including (but not limited to) C-reactive protein, plasma renin activity, aldosterone.

    baseline and 6 months

Study Arms (2)

Paricalcitol

ACTIVE COMPARATOR
Drug: Paricalcitol

Matching placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ParicalcitolDRUG

2 micrograms daily, peroral, 24 weeks

Also known as: Zemplar
Paricalcitol
PlaceboDRUG

2 micrograms daily, peroral, 24 weeks

Matching placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of a deceased donor kidney transplant at least 3 months after transplantation
  • Urinary protein to creatinine ratio (UPCR) \> 200 mg/g (20 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 \< 2.6 mmol/l
  • Intact parathormone value \> 30 pg/ml

You may not qualify if:

  • Subjects on vitamin D receptor activation therapy within 3 months prior to the first study visit
  • Acute kidney injury within 3 months of the first study visit
  • Subjects with poorly controlled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • Oblak M, Mlinsek G, Kandus A, Buturovic-Ponikvar J, Arnol M. Paricalcitol versus placebo for reduction of proteinuria in kidney transplant recipients: a double-blind, randomized controlled trial. Transpl Int. 2018 Dec;31(12):1391-1404. doi: 10.1111/tri.13323. Epub 2018 Aug 20.

    PMID: 30062716BACKGROUND

MeSH Terms

Conditions

ProteinuriaAlbuminuria

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Miha Arnol, M.D., Ph.D.

    University Medical Centre Ljubljana, Department of Nephrology

    PRINCIPAL INVESTIGATOR

  • Aljoša Kandus, M.D., Ph.D.

    University Medical Centre Ljubljana, Department of Nephrology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miha Arnol, M.D., Ph.D.

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 20, 2011

Study Start

July 1, 2012

Primary Completion

October 1, 2014

Study Completion

July 1, 2015

Last Updated

December 27, 2017

Record last verified: 2017-12

Locations

SL(1)