- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328302
Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
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.
Study Overview
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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 141 86
- Childrens Hospital, Karolinska University Hospital, Huddinge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Basement membrane thickness
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Mesangial expansion
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Secondary Outcome Measures
Outcome Measure |
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Microalbuminuria
|
Hypertension
|
Kidney Function
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24 hour ambulatory blood pressure
|
Collaborators and Investigators
Sponsor
Collaborators
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 and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH-AHM-0044-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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