Diabetic Kidney Disease
Conditions
Brief summary
* This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus. * Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt. This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following * Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months * Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after six months of treatment
Interventions
DRUGFexofenadine Pill
fexofenadine tablets 60 mg once daily will be taken for six months
DRUGPlacebo oral tablet
lactose oral tablet
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males or females aged ≥ 18 years * Confirmed diagnosis of Type 2 diabetes mellitus at least 6 months prior to screening * Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening * Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents
Exclusion criteria
* Type 1 diabetes mellitus * Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening) * Pregnant or lactating women * Chronic heart failure * Malignancy * Inflammatory or autoimmune disease * History of kidney disease other than diabetic nephropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in urinary albumin creatinine ratio (UACR) | After 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Urinary cyclophilin A | After 6 months |
| Urinary monocyte chemoattractant protein-1 (MCP-1) | After 6 months |
Countries
Egypt
Outcome results
None listed