NCT00328302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
Last Updated

May 19, 2006

Status Verified

June 1, 2000

First QC Date

May 18, 2006

Last Update Submit

May 18, 2006

Conditions

Diabetes, Type I

Keywords

DiabetesKidney function24 ambulatory blood pressureKidney biopsy

Outcome Measures

Primary Outcomes (2)

  • Basement membrane thickness

  • Mesangial expansion

Secondary Outcomes (4)

  • Hypertension

  • Microalbuminuria

  • Kidney Function

  • 24 hour ambulatory blood pressure

Interventions

CandesartanDRUG
PlaceboDRUG

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diabetes type 1 patient
  • Normotensive
  • Normoalbuminuric
  • Signed informed consent
  • Female and male
  • Over 17 years of age
  • Diabetes duration over 10 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital, Karolinska University Hospital, Huddinge

Stockholm, 141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 18270751DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

candesartan

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nina ES Perrin, PhD-student

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

    PRINCIPAL INVESTIGATOR

  • Ulla B Berg, Professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

September 1, 2000

Study Completion

April 1, 2006

Last Updated

May 19, 2006

Record last verified: 2000-06

Locations

SE(1)