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adding roflumilast to the standard therapy for diabetic nephropathy and studying the progression of many outcomes including urinary albumin to creatinine ratio, estimated GFR, biomarkers of diabetic nephropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| roflumilast arm | Experimental |
| |
| placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in urinary albumin creatinine ratio (UACR) | measuring UACR pre and post experiment and substracting and dividing on baseline level | Baseline and 3 months |
| Absolute change in Estimated glomerular filtration rate (eGFR) | substracting pre-treatment from post-treatment values of EGFR | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary pro-inflammatory cytokine MCP-1 | substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1 | Baseline and 3 months |
| Change in serum irisin level |
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Inclusion Criteria: diabetic patients with persistent micro- or macroalbuminuria despite treatment with the maximum tolerated dose of ACE inhibitors for at least 8 weeks before the screening and randomization
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hisham M Elnahhas, Pharm D | Contact | 01020515956 | 002 | PG_76772@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hisham M Elnahhas, Pharm D | Pharm D | Principal Investigator |
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data of outcomes and other research but not personal data are intended to be published in application to scientific journals
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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| Placebo | Drug | Placebo |
|
substracting pre-treatment from post-treatment values of serum irisin level
| Baseline and 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |