Diabetic NephropathiesPhase 3NCT04755946
Possible Role of Roflumilast in Diabetic Nephropathy
A Phase 3 study testing Roflumilast in people with Diabetic Nephropathies, run by Tanta University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2021to 10 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Diabetic Nephropathies
- Being tested
- Roflumilast, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| roflumilast arm | Experimental | Not described Receives: Drug: Roflumilast |
| placebo arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in urinary albumin creatinine ratio (UACR)
measuring UACR pre and post experiment and substracting and dividing on baseline level
Measured: Baseline and 3 months
Absolute change in Estimated glomerular filtration rate (eGFR)
substracting pre-treatment from post-treatment values of EGFR
Measured: Baseline and 3 months
Secondary outcomes (2)
Change in Urinary pro-inflammatory cytokine MCP-1
substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1
Measured: Baseline and 3 months
Change in serum irisin level
substracting pre-treatment from post-treatment values of serum irisin level
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start10 Mar 2021 (estimated)
- Primary completion10 Jun 2021 (estimated)
- Study completion10 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohammad Abd-El-Galil El-Nahhas, Tanta University
- Investigators
- Hisham M Elnahhas, Pharm D, Principal investigator, Pharm D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755946
- Sponsor's protocol ID
- Roflumilast in DN
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data of outcomes and other research but not personal data are intended to be published in application to scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT04755946
- Acronym / sponsor ID
- Roflumilast in DN
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 10 Jun 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| roflumilast arm | Experimental | Drug: Roflumilast |
| placebo arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilastadding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management | Drug | roflumilast arm |
| PlaceboPlacebo | Drug | placebo arm |
Primary outcome
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
Absolute change in Estimated glomerular filtration rate (eGFR)
Time frame: Baseline and 3 months
substracting pre-treatment from post-treatment values of EGFR
2 secondary outcomes
Change in Urinary pro-inflammatory cytokine MCP-1
Time frame: Baseline and 3 months
Change in serum irisin level
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No. data of outcomes and other research but not personal data are intended to be published in application to scientific journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham M Elnahhas, Pharm D principal investigator
Pharm D
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast in people with Diabetic Nephropathies, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hisham M Elnahhas, Pharm D (01020515956 ext. 002, PG_76772@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in urinary albumin creatinine ratio (UACR) (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.