Overview

This trial is active, not recruiting.

Condition diabetes, type i
Treatments candesartan, placebo
Phase phase 4
Sponsor Karolinska University Hospital
Collaborator AstraZeneca
Start date September 2000
End date April 2006
Trial size 13 participants
Trial identifier NCT00328302, SH-AHM-0044-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Basement membrane thickness
time frame:
Mesangial expansion
time frame:

Secondary Outcomes

Measure
Hypertension
time frame:
Microalbuminuria
time frame:
Kidney Function
time frame:
24 hour ambulatory blood pressure
time frame:

Eligibility Criteria

Male or female participants from 17 years up to 30 years old.

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

Additional Information

Official title Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
Principal investigator Nina ES Perrin, PhD-student
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2006.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.