A Double-Blind clinical trial of Benfotiamine Treatment in Diabetic Nephropathy

Phase 4

Recruiting

Conditions: 10012653
10029149
diabetes with kidney complications

Registration Number: NL-OMON31030

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 86

Inclusion Criteria

• Diabetes mellitus, with onset of disease after the age of 40 years
• Age: 50-70 years
• Patients are on treatment with angiotensin converting enzyme inhibitors (ACEi) and/or angiotension II antagonists (AIIA) in an unchanged dose for at least 3 months
• Active diabetic nephropathy as indicated by presence of microalbuminuria (30-300 mg/24 h urine) in at least two samples within 2-6 weeks in advance of inclusion in the trial
• HbA1c < 8.5%, a higher HbA1c < 9.5% is acceptable if the treating phycisian and the patient have accepted that striving for lower values is an unreachable goal (patients with high HbA1c values are the ones that one would expect to be benefit most from treatment with benfotiamine)
• eGFR (estimated by MDRD formula) > 30 ml/min
• Males and postmenopausal females
• Written informed consent

Exclusion Criteria

• Renal impairment by other causes than diabetes
• Stage of the disease more severe than indicated in Inclusion criteria
(macroalbuminuria or renal insufficiency)
• Severe hypoglycemia during the last 3 months, needing help from another person
• Severe hepatopathy (laboratory values about three times higher than normal)
• Endocrine disorders, e.g. hyper-/hypothyroidism
• Blood pressure > 160/90 mmHg
• Severe cardiac function disturbances and severe heart rhythm disturbances
• Neoplasms
• Severe general diseases or mental disorders making the participation in the study
impossible
• Drug abuse
• Female patients during pregnancy and lactation period and female patients with active menses during the past year
• Hypersensitivity to benfotiamine or other constituents of the study medication
• HbA1c >9.5%
• Use of vitamin B containing supplements during the last 3 months
• Use of NSAIDs more than 3 times per week (including self-medication)
• Participation in another study within one month before entering the benfotiamine
study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in urinary excretion of: (measured in 24-hour urine)<br /><br>• β2-microglobulin<br /><br>• Albumin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in urinary excretion of: (measured in 24-hour urine)<br /><br>• KIM-1 (kidney injury molecule-1)<br /><br>• MIF (macrophage inhibiting factor)<br /><br>• MCP-1 (monocyte chemo-attractant protein-1)<br /><br>• C3d<br /><br>• Urinary peptidomics<br /><br>• Reactive oxygen species, advanced glycation end-products (AGEs), and<br /><br>carbonylated albumin</p><br>