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Sponsors and Collaborators: |
Karolinska University Hospital AstraZeneca |
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Information provided by: | Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT00328302 |
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 |
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Diabetes, Type I |
Drug: Candesartan Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB |
Estimated Enrollment: | 13 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | April 2006 |
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.
Ages Eligible for Study: | 17 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Childrens Hospital, Karolinska University Hospital, Huddinge | |
Stockholm, Sweden, 141 86 |
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 |
Study ID Numbers: | SH-AHM-0044-01 |
Study First Received: | May 18, 2006 |
Last Updated: | May 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00328302 |
Health Authority: | Sweden: Medical Products Agency |
Diabetes Kidney function 24 ambulatory blood pressure Kidney biopsy |
Candesartan cilexetil Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Candesartan Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Angiotensin II Metabolic disorder Glucose Metabolism Disorders |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |