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

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ClinicalTrials.gov Identifier: NCT00328302
Recruitment Status : Unknown
Verified June 2000 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2006
Last Update Posted : May 19, 2006
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Karolinska University Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes, Type I Drug: Candesartan Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2000
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources




Primary Outcome Measures :
  1. Basement membrane thickness
  2. Mesangial expansion

Secondary Outcome Measures :
  1. Hypertension
  2. Microalbuminuria
  3. Kidney Function
  4. 24 hour ambulatory blood pressure


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: June 2000

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

Additional relevant MeSH terms:
Candesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action