Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Condition: Cardiorenal Syndrome; Chronic Allograft Nephropathy
MeSH terms: Kidney Diseases; Cardio-Renal Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for
      the management of chronic allograft dysfunction (CAD), protection and repair of kidney and
      heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have
      some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and
      phosphatemic complications alongside with great beneficial potential.
    

Detailed description: 
      Paricalcitol and calcitriol are identically effective for the management of chronic allograft
      dysfunction (CAD), protection and repair of kidney and heart, management of chronic
      renocardiac syndrome (CRS). Vitamin D can reduce progression of CAD. Activation of VDR in
      proximal part of nephron leads to rapid non-genomic beneficial effects with urgent multilevel
      protection of the most functionally important portion of kidney. Rising expression of VDR in
      distal portions of nephron stimulates slows genomic effects with some local repair responses.

      Hormone D may stimulate recruitment and activity of the different origin stem-progenitor
      cells (SPCs) with beneficial effects on different stages of regeneration by force of para-
      and autocrine activity. SPCs are revealing mostly in interstitium and among fibroblast-like
      cells. Vitamin D did not confirm efficacy as a tool for management of mesenchymal stem cells
      (MSCs) in human however it needs more research experimental evidences due to multifactorial
      influence on SPCs in human being including immunosuppressive and bone-marrow-related effects
      of cyclosporine in kidney transplant (Tx) patients. Paricalcitol and calcitriol can slow down
      migration and infiltration of MSC into interstitium and vessel wall. The side population of
      mature and SPCs (first of all, with bone-marrow and mesenchymal phenotype) is the most
      metabolically and functionally active portion of cells with high sensitivity to vitamin D
      receptor (VDR) activation that responsible for repair of tissue.

      The most optimal scheme of treatment with vitamin D in patients with CAD and CRS is an
      administration of paricalcitol with dose 2-4 μg daily and supplemental intake of vitamin D
      including special diet, multivitamins, and others with optimal dose until 1800 international
      units (IU) but excluding insolation as a factor of skin carcinoma. High-dose medicinal intake
      of calcitriol (until 6 mcg and higher) showed relatively high efficacy but rather excessive
      level of complications mediated with mineral metabolism.

      Paricalcitol and calcitriol may significantly improve contractility of myocardium and reduce
      cardiovascular risk, heart failure (HF) and hypertension with some beneficial effects on
      cardiorenal axis and renin-angiotensin-aldosterone system.
    

Intervention name(s): Paricalcitol; Calcitriol; Cholecalciferol; Supplemental
Intervention type(s): Drug; Drug; Drug; Dietary Supplement
Intervention description(s): paricalcitol group (6-8 μg daily per os - orally - without special diet); calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D); cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day); intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Other intervention name(s): Zemplar; Rocaltrol; Fosamax; Diet, sun, multivitamin drugs, food
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic allograft nephropathy; stem-progenitor cells; cardiorenal syndrome; calcitriol; paricalcitol; cholecalciferol; cardiac repair; renal repair