Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328302
Status:
UNKNOWN
Last Update Posted:
2006-05-19
First Post:
2006-05-18
Brief Title:
Diabetes Type 1 Treatment Study AtacandPlacebo After Kidney Biopsy
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology Kidney Function and Metabolic Control Natural History and Effect of ARB
Status:
UNKNOWN
Status Verified Date:
2000-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The type 1 diabetes patients who were still normoalbuminuric and normotensive after 17 years duration and a second research kidney biopsy could enter the double blind treatment study of Atacand or Placebo
The treatment study continues for five years treatment and ends with a third kidney biopsy
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo
The treatment study continues for five years treatment and ends with a third kidney biopsy
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo
Detailed Description:
46 patients performed a first kidney biopsy between 1992-1994 After 6 years 29 accepted to perform a second biopsy During the follow-up 10 patients developed complications ie hypertension or microalbuminuria 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy 19 patients with two kidney biopsies were still normoalbuminuric and normotensive 13 of them entered the double-blind treatment study of Atacand or Placebo 6 denied to participate in the treatment study
The treatment study will continue for 5 years and will end with a third kidney biopsy Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy
The treatment study will continue for 5 years and will end with a third kidney biopsy Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy
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