Possible Role of Roflumilast in Diabetic Nephropathy

Sponsor
Tanta University
Study ID
NCT04755946
Phase
PHASE3
Status
Unknown

Conditions

  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 10, 2021
Status verified
Feb 2021
Primary completion
Jun 10, 2021
Completion
Jul 10, 2021

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: roflumilast arm
  • Placebo Comparator: placebo arm

Primary Outcome Measure

Percent change in urinary albumin creatinine ratio (UACR) [ Time Frame: Baseline and 3 months ]

Central Contacts

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