Possible Role of Roflumilast in Diabetic Nephropathy

February 15, 2021 updated by: Hisham Mohammad Abd-El-Galil El-Nahhas, Tanta University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo arm
Drug: Placebo
Placebo
Experimental: roflumilast arm
Drug: Roflumilast
adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in urinary albumin creatinine ratio (UACR)
Time Frame: Baseline and 3 months
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)
Time Frame: Baseline and 3 months
substracting pre-treatment from post-treatment values of EGFR
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary pro-inflammatory cytokine MCP-1
Time Frame: Baseline and 3 months
substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1
Baseline and 3 months
Change in serum irisin level
Time Frame: Baseline and 3 months
substracting pre-treatment from post-treatment values of serum irisin level
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 10, 2021

Primary Completion (Anticipated)

June 10, 2021

Study Completion (Anticipated)

July 10, 2021

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Roflumilast in DN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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