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Possible Role of Roflumilast in Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathies

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Roflumilast

Placebo

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

roflumilast arm

placebo arm

Arm Description

Outcomes

Primary Outcome Measures

Percent change in urinary albumin creatinine ratio (UACR)

measuring UACR pre and post experiment and substracting and dividing on baseline level

Absolute change in Estimated glomerular filtration rate (eGFR)

substracting pre-treatment from post-treatment values of EGFR

Secondary Outcome Measures

Change in Urinary pro-inflammatory cytokine MCP-1

substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1

Change in serum irisin level

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

Full Information

NCT ID

NCT04755946

First Posted

February 13, 2021

Last Updated

February 15, 2021

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04755946

Brief Title

Possible Role of Roflumilast in Diabetic Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 10, 2021 (Anticipated)

Primary Completion Date

June 10, 2021 (Anticipated)

Study Completion Date

July 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

roflumilast arm

Arm Type

Experimental

Arm Title

placebo arm

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Roflumilast

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percent change in urinary albumin creatinine ratio (UACR)

Description

measuring UACR pre and post experiment and substracting and dividing on baseline level

Time Frame

Baseline and 3 months

Title

Absolute change in Estimated glomerular filtration rate (eGFR)

Description

substracting pre-treatment from post-treatment values of EGFR

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

Change in Urinary pro-inflammatory cytokine MCP-1

Description

substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1

Time Frame

Baseline and 3 months

Title

Change in serum irisin level

Description

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

Time Frame

Baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hisham M Elnahhas, Pharm D

Phone

01020515956

Ext

002

PG_76772@pharm.tanta.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hisham M Elnahhas, Pharm D

Organizational Affiliation

Pharm D

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

data of outcomes and other research but not personal data are intended to be published in application to scientific journals

Learn more about this trial

Possible Role of Roflumilast in Diabetic Nephropathy

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