Possible Role of Roflumilast in Diabetic Nephropathy

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04755946

Enrollment

Registered

2021-02-16

Start date

2021-03-10

Completion date

2021-07-10

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathies

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

Interventions

DRUGRoflumilast

adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactHisham M Elnahhas, Pharm D

PG_76772@pharm.tanta.edu.eg01020515956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026