Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy - Full Text View

Sponsor:	Karolinska University Hospital
Collaborator:	AstraZeneca
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00328302

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Type 1 High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

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):

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.

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 February 09, 2012