Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01265615
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2010-12-22
Brief Title:
Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Sponsor:
Ural State Medical University
Organization:
Ural State Medical University
Study Overview
Official Title:
Phase 4 Study of Paricalcitol and Calcitriol for Reparative Management of Chronic Allograft Dysfunction and Renocardiac Syndrome in Vitamin D Insufficient Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None