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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00328302
First received: May 18, 2006
Last updated: NA
Last verified: June 2000
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes, Type I
 Drug: Candesartan
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Basement membrane thickness
  • Mesangial expansion

Secondary Outcome Measures:
  • Hypertension
  • Microalbuminuria
  • Kidney Function
  • 24 hour ambulatory blood pressure

Estimated Enrollment: 13
Study Start Date: September 2000
Estimated Study Completion Date: April 2006
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

Ages Eligible for Study:   17 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328302

Locations
Sweden
Childrens Hospital, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
AstraZeneca
Investigators
Principal Investigator: Nina ES Perrin, PhD-student Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm
Study Director: Ulla B Berg, Professor Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden
  More Information

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00328302     History of Changes
Other Study ID Numbers: SH-AHM-0044-01
Study First Received: May 18, 2006
Last Updated: May 18, 2006
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska University Hospital:
Diabetes
Kidney function
24 ambulatory blood pressure
Kidney biopsy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Candesartan
 Candesartan cilexetil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013