Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320879
Status:
COMPLETED
Last Update Posted:
2006-05-18
First Post:
2006-05-01
Brief Title:
Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication At inclusion previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg od for the entire study Following two months wash-out baseline patients will be treated randomly with irbesartan 300 600 and 900 mg od each dose for two months End-points evaluated at the end of each study period include urinary albumin excretion rate UAE mean of three 24-hrs collections 24-hrs blood pressure ABP and GFR 51Cr-EDTA
Detailed Description:
Aim
The primary aim of our study is to evaluate the antiproteinuric effect of irbesartan 300 600 and 900 mg once daily in type 2 diabetic patients with microalbuminuria Secondary to evaluate the effect on 24-h ambulatory blood pressure glomerular filtration rate GFR urinary TGF beta excretion and markers of endothelial dysfunction and finally to evaluate the association between treatment response and genotypes with possible implications for the risk of cardiovascular disease
Patients 60 type 2 diabetic patients with persistent microalbuminuria at least two out of three 24-h urinary collections with albumin excretion between 30 and 300 mg24-h
Duration of study 38 weeks 8 weeks wash-out and 30 weeks of double-blind randomized cross-over treatment with irbesartan 300 600 and 900 mg for 10 weeks at each dose level
Design The study consists of an eight week wash-out period followed by a double-blind randomized three 10 week treatment period cross-over trial please see enclosed flow chart
Wash-out period Eight weeks prior to randomization all previous antihypertensive medication is discontinued and replaced by hydrochlorothiazide 25 mg once daily throughout the entire study period Hydrochlorothiazide is added to reduce blood pressure elevation and edema formation during the trial and to eliminate the influence of varying dietary salt intake on the effects of irbesartan during the double blind treatment periods
Double-blind cross-over periods All patients receive treatment with irbesartan 300 600 and 900 mg once daily in random order without wash-out between treatment periods All treatment periods are of 10 weeks duration They consist of an initial two week titration period on irbesartan 300 mg od to minimize the risk of adverse events including hypotension during cross-over in doses followed by an eight week period on the full dose for the given treatment level
For safety reasons blood pressure serum potassium and serum creatinine will be measured 4 weeks after the beginning of each treatment period two weeks after the full dose of the treatment period is reached
End-points are evaluated after the wash-out period baseline and at the end of each treatment period
Methods Albuminuria is assessed by turbidimetry in three 24-h urinary samples 24-h ambulatory blood pressure by the Takeda TM-24202421 device GFR by plasma clearance of 51Cr-EDTA DNA will be extracted from a venous sample to determine genotypes with possible implications for the risk of cardiovascular disease Initially we will evaluate the influence of the ACEID- Angiotensin II type I receptor A1166C - and the angiotensinogen M235T polymorphisms
Endpoints Primary endpoint change in albuminuria Secondary endpoints 24-h ambulatory blood pressure glomerular filtration rate GFR and to evaluate the association between treatment response genotypes with possible implications for the risk of cardiovascular disease
The primary aim of our study is to evaluate the antiproteinuric effect of irbesartan 300 600 and 900 mg once daily in type 2 diabetic patients with microalbuminuria Secondary to evaluate the effect on 24-h ambulatory blood pressure glomerular filtration rate GFR urinary TGF beta excretion and markers of endothelial dysfunction and finally to evaluate the association between treatment response and genotypes with possible implications for the risk of cardiovascular disease
Patients 60 type 2 diabetic patients with persistent microalbuminuria at least two out of three 24-h urinary collections with albumin excretion between 30 and 300 mg24-h
Duration of study 38 weeks 8 weeks wash-out and 30 weeks of double-blind randomized cross-over treatment with irbesartan 300 600 and 900 mg for 10 weeks at each dose level
Design The study consists of an eight week wash-out period followed by a double-blind randomized three 10 week treatment period cross-over trial please see enclosed flow chart
Wash-out period Eight weeks prior to randomization all previous antihypertensive medication is discontinued and replaced by hydrochlorothiazide 25 mg once daily throughout the entire study period Hydrochlorothiazide is added to reduce blood pressure elevation and edema formation during the trial and to eliminate the influence of varying dietary salt intake on the effects of irbesartan during the double blind treatment periods
Double-blind cross-over periods All patients receive treatment with irbesartan 300 600 and 900 mg once daily in random order without wash-out between treatment periods All treatment periods are of 10 weeks duration They consist of an initial two week titration period on irbesartan 300 mg od to minimize the risk of adverse events including hypotension during cross-over in doses followed by an eight week period on the full dose for the given treatment level
For safety reasons blood pressure serum potassium and serum creatinine will be measured 4 weeks after the beginning of each treatment period two weeks after the full dose of the treatment period is reached
End-points are evaluated after the wash-out period baseline and at the end of each treatment period
Methods Albuminuria is assessed by turbidimetry in three 24-h urinary samples 24-h ambulatory blood pressure by the Takeda TM-24202421 device GFR by plasma clearance of 51Cr-EDTA DNA will be extracted from a venous sample to determine genotypes with possible implications for the risk of cardiovascular disease Initially we will evaluate the influence of the ACEID- Angiotensin II type I receptor A1166C - and the angiotensinogen M235T polymorphisms
Endpoints Primary endpoint change in albuminuria Secondary endpoints 24-h ambulatory blood pressure glomerular filtration rate GFR and to evaluate the association between treatment response genotypes with possible implications for the risk of cardiovascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None