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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-04-30

Brief Summary

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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

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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

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Diabetes, Type I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Candesartan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nina ES Perrin, PhD-student

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm

Ulla B Berg, Professor

Role: STUDY_DIRECTOR

Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden

Locations

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Childrens Hospital, Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED

PMID: 18270751 (View on PubMed)

Other Identifiers

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SH-AHM-0044-01

Identifier Type: -

Identifier Source: org_study_id