Possible Role of Roflumilast in Diabetic Nephropathy

Diabetic Nephropathies Clinical Trial

Official title:

Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04755946
• Other study ID #: Roflumilast in DN
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 10, 2021
• Est. completion date: July 10, 2021

Study information

• Verified date: February 2021
• Source: Tanta University
• Contact: Hisham M Elnahhas, Pharm D
• Phone: 01020515956
• Email: PG_76772[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Roflumilast
adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Absolute change in Estimated glomerular filtration rate (eGFR)	substracting pre-treatment from post-treatment values of EGFR	Baseline and 3 months
Secondary	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
Secondary	Change in serum irisin level	substracting pre-treatment from post-treatment values of serum irisin level	Baseline and 3 months