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

Disorder of Transplanted Kidney research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Disorder of Transplanted Kidney

Proteinuria

Albuminuria

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Paricalcitol2 micrograms daily, peroral, 24 weeks

Drug:Placebo2 micrograms daily, peroral, 24 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Paricalcitol

Matching placebo

Study Status

Completed

Start Date: July 2012

Completed Date: July 2015

Phase: Phase 3

Type: Interventional

Design:

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

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

Study sponsors, principal investigator, and references

Principal Investigator: Miha Arnol, M.D., Ph.D.

Lead Sponsor: University Medical Centre Ljubljana

Collaborator: Abbott

More information:https://clinicaltrials.gov/show/NCT01436747

Arnol M, Oblak M, Mlinsek G, Bren AF, Buturović-Ponikvar J, Kandus A. Proteinuria in kidney transplant recipients: prevalence in a national cohort and study design of the effect of paricalcitol for reduction of proteinuria. Transplant International 2011; 24(2): 185(A204).

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