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Possible Role of Roflumilast in Diabetic Nephropathy

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04755946
Collaborator
(none)
48
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy
Anticipated Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Jun 10, 2021
Anticipated Study Completion Date :
Jul 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: roflumilast arm

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

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Absolute change in Estimated glomerular filtration rate (eGFR) [Baseline and 3 months]

    substracting pre-treatment from post-treatment values of EGFR

Secondary Outcome Measures

  1. 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

  2. Change in serum irisin level [Baseline and 3 months]

    substracting pre-treatment from post-treatment values of serum irisin level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: Hisham M Elnahhas, Pharm D, Pharm D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hisham Mohammad Abd-El-Galil El-Nahhas, Pharm D, Tanta University
ClinicalTrials.gov Identifier:
NCT04755946
Other Study ID Numbers:
  • Roflumilast in DN
First Posted:
Feb 16, 2021
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies

Study Results

No Results Posted as of Feb 16, 2021