Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB|
- Basement membrane thickness
- Mesangial expansion
- Kidney Function
- 24 hour ambulatory blood pressure
|Study Start Date:||September 2000|
|Estimated Study Completion Date:||April 2006|
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 i.e. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328302
|Childrens Hospital, Karolinska University Hospital, Huddinge|
|Stockholm, Sweden, 141 86|
|Principal Investigator:||Nina ES Perrin, PhD-student||Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm|
|Study Director:||Ulla B Berg, Professor||Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden|