NCT00328302

Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy

Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (planned)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 30 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Diabetes, Type I

Interventions

Type	Name	Description
DRUG	Candesartan
DRUG	Placebo

Timeline

• Start date: 2000-09-01
• Completion: 2006-04-01
• First posted: 2006-05-19
• Last updated: 2006-05-19

Locations

1 site across 1 country: Sweden