Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156364
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2005-09-07
Brief Title:
Studies of Organ Transplantation in Animals and Man
Sponsor:
Michael Mauer MD
Organization:
University of Minnesota
Study Overview
Official Title:
Ii-Pancreas Transplantation in Man Long Term Effects of Cyclosporine CSA and Tacrolimus FK506 on Renal Structure and Function Studies of the Renal Interstitium Type I Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2014-12
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:
A To study the effects of pancreas transplantation PT on the structural abnormalities of diabetic nephropathy DN in patients with type 1 insulin-dependent diabetes mellitus type 1 D These studies will address the influence of long-term normoglycemia on two stages of diabetic renal disease
Due to the difficulties encountered for recruitment of patients to agree to undergo a GFR and a native kidney biopsy in conjunction with their clinical evaluation visit for transplant we are now focusing efforts on obtaining skin biopsies previous to transplant and then at regular intervals 3 6 and 9 months and yearly following a successful transplantation
Pancreas Transplantation Alone PTA To determine at 5 10 and 15 years after PTA the effects of normoglycemia on the established lesions of DN in the long-term type 1 D patients own kidneys
Islet Transplantation Alone ITA To determine at 5 years after ITA the effects of normoglycemia on the early lesions of DN in type 1 D patients own kidneys
Pancreas Transplantation after Kidney Transplantation PAK To determine at 5-10 years the effects of normoglycemia on the early structural lesions of DN in kidneys transplanted some years earlier into type 1 D recipients
Hypothesis The benefits of PT on the early glomerular lesions of DN will be demonstrable after 5 years in kidneys exposed to diabetes for a short duration while in patients with long-standing type 1 D and more advanced glomerular DN lesions longer exposure to euglycemia is necessary to demonstrate arrest or regression of the lesions
Due to the difficulties encountered for recruitment of patients to agree to undergo a GFR and a native kidney biopsy in conjunction with their clinical evaluation visit for transplant we are now focusing efforts on obtaining skin biopsies previous to transplant and then at regular intervals 3 6 and 9 months and yearly following a successful transplantation
Pancreas Transplantation Alone PTA To determine at 5 10 and 15 years after PTA the effects of normoglycemia on the established lesions of DN in the long-term type 1 D patients own kidneys
Islet Transplantation Alone ITA To determine at 5 years after ITA the effects of normoglycemia on the early lesions of DN in type 1 D patients own kidneys
Pancreas Transplantation after Kidney Transplantation PAK To determine at 5-10 years the effects of normoglycemia on the early structural lesions of DN in kidneys transplanted some years earlier into type 1 D recipients
Hypothesis The benefits of PT on the early glomerular lesions of DN will be demonstrable after 5 years in kidneys exposed to diabetes for a short duration while in patients with long-standing type 1 D and more advanced glomerular DN lesions longer exposure to euglycemia is necessary to demonstrate arrest or regression of the lesions
Detailed Description:
These continuation studies focus on large pancreas PTx and kidney KTx transplant populations of type 1 diabetic D patients pts in order to better understand diabetic nephropathy DN the leading cause of renal failure Objectives are a to determine whether PTx can more readily arrest or reverse the early vs the more established lesions of DN b to continue studies of renal structural-functional relationships in DN with emphasis on the multifaceted pathologic DN lesions including glomerular vascular interstitial lesions and glomerular-tubular connections c to continue studies of DN natural history and the role of renal biopsy in predicting outcome d to quantitate and understand the basis of atubular glomeruli AG in DN e to elucidate glomerular glom epithelial cell abnormalities in DN f to study the glom extracellular matrix abnormalities of DN g to study the recurrence of DN in the KTx h to study the moleculargenetic basis of DN and develop cellular markers of DN risk i to determine the long-term 10-15 yr structural consequences of cyclosporine CSA on the native kidneys of PTx recipients and j to determine the shorter-term 5 yr consequences of Prograf on the native kidneys of PTx recipients and compare these with those seen after 5 years of CSA treatment Together these studies will help to elucidate the pathogenesis and natural history of DN unravel some of the molecular and genetic aspects of this disease describe the dynamics of DN reversal in PTx pts and recurrence in KTx pts and expand our knowledge of the nephrotoxic effects of calcinosis inhibitors
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH 2P01-DK13083-38 | OTHER_GRANT | NIH | None |