Overview

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

Status:
Unknown status
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karolinska University Hospital
Collaborator:
AstraZeneca
Treatments:
Candesartan
Criteria
Inclusion Criteria:

- Diabetes type 1 patient

- Normotensive

- Normoalbuminuric

- Signed informed consent

- Female and male

- Over 17 years of age

- Diabetes duration over 10 years

Exclusion Criteria:

- Hypertension

- Microalbuminuria

- Pregnancy

- Lactation

- Reduced kidney function

- Artery stenosis

- Kidney transplantation

- Allergy to the medication in the study

- Reduced liver function

- Alcohol or drug abuse

- Participation in another drug or clinical test during last 30 days

- Severe diseases i.e. malignancy

- Previously enrolment of the present study