Possible Role of Roflumilast in Diabetic Nephropathy

NCT04755946 | Unknown Phase 3

• 1 other identifier: Roflumilast in DN
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (2)

• 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

• Absolute change in Estimated glomerular filtration rate (eGFR)

  substracting pre-treatment from post-treatment values of EGFR

  Baseline and 3 months

Secondary Outcomes (2)

• Change in Urinary pro-inflammatory cytokine MCP-1

  Baseline and 3 months

• Change in serum irisin level

  Baseline and 3 months

Study Arms (2)

roflumilast arm

EXPERIMENTAL

Drug: Roflumilast

placebo arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Roflumilast DRUG

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

roflumilast arm

Placebo DRUG

Placebo

placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Hisham M Elnahhas, Pharm D

  Pharm D

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham M Elnahhas, Pharm D

CONTACT

01020515956; PG_76772@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 16, 2021
• Study Start: March 10, 2021
• Primary Completion: June 10, 2021
• Study Completion: July 10, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share