Possible Role of Roflumilast in Diabetic Nephropathy

Phase 3

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Placebo; Drug: Roflumilast

• Registration Number: NCT04755946
• Lead Sponsor: Tanta University

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 nephropathy

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16
• Study Start: 2021-03-10
• Primary Completion: 2021-06-10
• Study Completion: 2021-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo arm	Placebo	-
roflumilast arm	Roflumilast	-

Primary Outcome Measures

Name	Time	Method
Percent change in urinary albumin creatinine ratio (UACR)	Baseline and 3 months	measuring UACR pre and post experiment and substracting and dividing on baseline level
Absolute change in Estimated glomerular filtration rate (eGFR)	Baseline and 3 months	substracting pre-treatment from post-treatment values of EGFR

Secondary Outcome Measures

Name	Time	Method
Change in Urinary pro-inflammatory cytokine MCP-1	Baseline and 3 months	substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1
Change in serum irisin level	Baseline and 3 months	substracting pre-treatment from post-treatment values of serum irisin level