Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
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|ClinicalTrials.gov Identifier: NCT00328302|
Recruitment Status : Unknown
Verified June 2000 by Karolinska University Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 19, 2006
Last Update Posted : May 19, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes, Type I||Drug: Candesartan Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB|
|Study Start Date :||September 2000|
|Estimated Study Completion Date :||April 2006|
- Basement membrane thickness
- Mesangial expansion
- Kidney Function
- 24 hour ambulatory blood pressure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|