The effect of paricalcitol for reduction of urinary protein excretion in kidney transplant recipients

Conditions: Proteinuria in kidney transplant recipients
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-006120-20-SI

Lead Sponsor: niversity Medical Centre Ljubljana

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Recipients of a deceased donor kidney transplant at least three months after transplantation.
Patients are on stable immunosuppression at least three months before study enrollment.
Recipient age = 18 years.
Patients are on stable doses of antihypertensive medications for at least three months before study enrollment.
Patients are not expected to begin dialysis for at least six months.
Estimated glomerular filtration rate > 15 mL/min/1.73 m2.
UPCR > 22 mg/mmol (> 200 mg/g), as determined by the geometric mean of three second morning void urine samples.
Corrected serum calcium concentration = 2.5 mmol/L.
Intact parathoromone concentration > 35 pg/mL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients on vitamin D receptor activation therapy within three months prior to the first study visit.
Patients with diagnosis of primary focal segmental glomerulosclerosis (FSGS).
Patients with acute kidney injury within three months prior to the first study visit.
Patients with poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Difference in urinary protein to creatinine ratio (UPCR) between paricalcitol and placebo study group patients.;Secondary Objective: The proportion of patients achieving at least a 15 mg/mmol reduction in the last on-treatment UPCR level form the baseline.<br><br>Difference in urinary albumin to creatinine ratio (UACR) between paricalcitol and placebo study groups.<br><br>Difference in 24-hour urinary protein excretion between paricalcitol and placebo study groups.<br>;Primary end point(s): Difference in urinary protein to creatinine ratio (UPCR) in second morning void urine between paricalcitol and placebo study group patients after 24 weeks of treatment.;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 24 weeks;Secondary end point(s): The proportion of patients achieving at least a 15 mg/mmol reduction in the last on-treatment UPCR level form the baseline.<br><br>Difference in urinary albumin to creatinine ratio (UACR) in second morning void urine between paricalcitol and placebo study groups after 24 weeks of treatment.<br><br>Difference in 24-hour urinary protein excretion between paricalcitol and placebo study groups after 24 weeks of treatment.