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

Diabetes, Type I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00328302
• Other study ID #: SH-AHM-0044-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 18, 2006
• Last updated: May 18, 2006
• Start date: September 2000
• Est. completion date: April 2006

Study information

• Verified date: June 2000
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Type I

Intervention

Drug:
• Candesartan

• Placebo

Locations

Country	Name	City	State
Sweden	Childrens Hospital, Karolinska University Hospital, Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basement membrane thickness
Primary	Mesangial expansion
Secondary	Hypertension
Secondary	Microalbuminuria
Secondary	Kidney Function
Secondary	24 hour ambulatory blood pressure