Benfotiamine in Diabetic Nephropathy (Benfo)
|ClinicalTrials.gov Identifier: NCT00565318|
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : November 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Benfotiamine Drug: Placebo||Phase 4|
There is a worldwide increase in prevalence in type 2 diabetes mellitus, which is being paralleled by an increasing number of patients reaching dialysis because of diabetic nephropathy. Much of the fivefold increase in patients receiving dialysis treatment that occurred over the past two decades is attributable to type 2 diabetes and diabetic nephropathy. Diabetes is now the leading cause of end-stage renal disease (ESRD), with more than 40% of all new cases of ESRD occurring in patients with diabetes.
Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We hypothesize that benfothiamine supplementation in patients with diabetic nephropathy will ameliorate the effects of both albuminuria/proteinuria and hyperglycaemia on oxidative stress and advanced glycation end-products (AGEs) accumulation in renal tissue, and thereby decrease inflammatory responses and fibrotic responses, causing slowing down of progression to ESRD as a consequence.
The intervention duration is 12 weeks for each group.
- Group A: Benfotiamine (300 mg) 3x 1 film coated tablet daily (900 mg daily dose benfotiamine)
- Group B: Placebo 3x 1 film coated tablet daily
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|Active Comparator: A||
3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
|Placebo Comparator: B||
3x 1 film coated tablet daily. Duration: 12 weeks.
Other Name: Placebo, Wörwag Pharma GmbH & Co. KG
- Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin [ Time Frame: 12 weeks ]
- Change in urinary excretion of: β2 microglobulin, macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs). [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565318
|Isala Klinieken Hospital|
|Zwolle, Netherlands, 8000 GK|
|Study Director:||G J Navis, MD, PhD||University Medical Center Groningen|
|Principal Investigator:||H JG Bilo, MD, PhD||Isala|