Status:
UNKNOWN
Possible Role of Roflumilast in Diabetic Nephropathy
Lead Sponsor:
Tanta University
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 n...
Eligibility Criteria
Inclusion
- 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
- Type I or II diabetic patient with stage 2 CKD (eGFR = 60 - 89 ml/min) ,stage 3 CKD (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min)
Exclusion
- moderate to severe hepatic disease (Child-Pugh B or C) severe renal disease (eGFR\<15 ml/min) body-mass index below 25 kg/m2 concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) known psychiatric illness, congestive heart disease patients with allergy for roflumilast pregnant and lactating women
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04755946
Start Date
March 10 2021
End Date
July 10 2021
Last Update
February 16 2021
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