Clinical trial NCT00328302: Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
Official title: Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes, Type I
Keywords: Diabetes
Kidney function
24 ambulatory blood pressure
Kidney biopsy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2006-05-19
Enrollment: 13
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Basement membrane thickness
measure: Mesangial expansion
Secondary outcomes:
measure: Hypertension
measure: Microalbuminuria
measure: Kidney Function
measure: 24 hour ambulatory blood pressure
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Childrens Hospital, Karolinska University Hospital, Huddinge
Study officials:
affiliation: Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm
name: Nina ES Perrin, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden
name: Ulla B Berg, Professor
role: STUDY_DIRECTOR
References:
citation: Perrin NE, Jaremko GA, Berg UB. The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial. Pediatr Nephrol. 2008 Jun;23(6):947-54. doi: 10.1007/s00467-008-0745-x.