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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Selective Vitamin D Receptor Activation With Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients: a Randomized Controlled Tria

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.


Detailed Summary:

Kidney transplantation is the treatment of choice for end-stage renal disease patients. In comparison to dialysis it offers longer survival and better quality of life to certain patients with end stage renal disease. In the last two decades, short-term (i.e. 1- and 3-year) kidney transplant survival has increased significantly and is currently exceeding 90% in state-of-the-art transplant centers. This is considered to be due to the safe and effective immunosuppressive therapy in the early post-transplant period, and to the careful management of patients with chronic renal disease (CRD) before and after the transplantation. In spite of the progress described above, long-term (i.e. 5- and 10-year) transplant survival has not significantly improved over the recent decades. Two main causes for long-term loss of transplanted kidneys are the development of the transplant chronic kidney disease (CKD) (i.e. chronic allograft nephropathy) and patient death with a functioning transplant due to cardiovascular events.

Proteinuria (> 150 mg of proteins in urine per day) is a manifestation of kidney disease and is an important risk factor for CKD progression. This applies also to kidney transplant recipients. Studies have shown that proteinuria is present in 20-40% of transplanted patients. According to observational studies, proteinuria is an independent predictor for CKD progression and transplant failure, as well as of increased risk for cardiovascular events. In CKD patients, treatment with renin-angiotensin-aldosterone system inhibitors (RAAS - angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone receptor blockers) reduces proteinuria and thus slows the renal disease progression. In spite of the demonstrated renoprotective effect of RAAS inhibitors, the risk for CKD progression remains high. Furthermore, large epidemiological studies have not sho
Sponsor: University Medical Centre Ljubljana

Current Primary Outcome: The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage change in urinary albumin to creatinine ratio (UACR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ]
  • The percentage change in 24-hour urinary protein excretion form baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ]
  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Medical Centre Ljubljana

Dates:
Date Received: September 14, 2011
Date Started: July 2012
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017