Diabetic NephropathyPhase 3NCT02689778
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
A Phase 3 study testing Pirfenidone in people with Diabetic Nephropathy and Albuminuria, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy, Albuminuria
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2016to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) less than 35 kg/m2
- Diagnosis of diabetes mellitus type 2
- Glomerular filtration rate of 15-89 ml/min
- Albuminuria ≥30 mg/24 h and < 3.5 g/24 h
- Individuals with blood pressure less than 140/90 mmHg or treated with stable doses of anti-hypertensive drugs.
- Glycated hemoglobin <10%
Who cannot join
- Another etiology of renal disease (autoimmune diseases, polycystic kidney disease)
- Repeated urinary tract infections (more than three episodes in the past year)
- Photosensitivity to any drug
- Liver disease
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Mexico City, 14080
About this study
It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets for this entity. Current treatment options are based on the glycemic control, blood pressure control, as well as the use of medications such as angiotensin-converting enzyme inhibitors and Angiotensin II receptor antagonists, these actions are not enough to stop progression. Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties. Although the specific mechanism is unknown, pirfenidone interferes with the expression, secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients with type 2 diabetes and nephropathy. The period of time the treatment will be administered will be of 12 months, 62 patients will be included. The primary outcome will be improvement in glomerular filtration rate. The secondary outcomes will be number of patients requiring replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF - β. Change in these parameters will be evaluated at the end of the treatment period (12 months). Throughout the study the incidence of adverse events will be recorded, wich will allow us to learn about the safety and security of the drug in this population.
- Conditions
- Diabetic Nephropathy, Albuminuria
- Being tested
- Pirfenidone, Placebo
- Keywords
- Pirfenidone, Diabetic nephropathy
- Medical subject headings
- Diabetic Nephropathies, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called Kitoscell LP
Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
PlaceboDrug
Identical tablets without active substance
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months. Receives: Drug: Pirfenidone |
| Placebo | Placebo comparator | Oral placebo with breakfast and with dinner for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of oral pirfenidone (1800 mg) in albuminuria
Measured: 12 months
Effect of oral pirfenidone (1800 mg) in glomerular filtration rate
Measured: 12 months
Secondary outcomes (1)
Number of patients with treatment related adverse events
hypersensitivity, photosensitivity, liver function test alteration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Medifarma, S. A. de C. V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689778
- Sponsor's protocol ID
- 1497
- Status last verified
- Aug 2019
- First submitted
- 12 Feb 2016
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02689778
- Acronym / sponsor ID
- 1497
- Conditions
- Diabetic Nephropathy, Albuminuria
- Keywords
- Pirfenidone, Diabetic nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Grupo Medifarma, S. A. de C. V.
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets for this entity. Current treatment options are based on the glycemic control, blood pressure control, as well as the use of medications such as angiotensin-converting enzyme inhibitors and Angiotensin II receptor antagonists, these actions are not enough to stop progression. Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties. Although the specific mechanism is unknown, pirfenidone interferes with the expression, secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients with type 2 diabetes and nephropathy. The period of time the treatment will be administered will be of 12 months, 62 patients will be included. The primary outcome will be improvement in glomerular filtration rate. The secondary outcomes will be number of patients requiring replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF - β. Change in these parameters will be evaluated at the end of the treatment period (12 months). Throughout the study the incidence of adverse events will be recorded, wich will allow us to learn about the safety and security of the drug in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: PirfenidoneOral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo with breakfast and with dinner for 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) less than 35 kg/m2
- Diagnosis of diabetes mellitus type 2
- Glomerular filtration rate of 15-89 ml/min
- Albuminuria ≥30 mg/24 h and < 3.5 g/24 h
- Individuals with blood pressure less than 140/90 mmHg or treated with stable doses of anti-hypertensive drugs.
Key exclusion criteria (6 listed)
- Another etiology of renal disease (autoimmune diseases, polycystic kidney disease)
- Repeated urinary tract infections (more than three episodes in the past year)
- Photosensitivity to any drug
- Liver disease
- Pregnancy
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 |
|---|---|---|
| PirfenidoneAlso: Kitoscell LPOral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months. | Drug | Pirfenidone |
| PlaceboIdentical tablets without active substance | Drug | Placebo |
Primary outcome
Effect of oral pirfenidone (1800 mg) in albuminuria
Time frame: 12 months
Effect of oral pirfenidone (1800 mg) in glomerular filtration rate
Time frame: 12 months
1 secondary outcome
Number of patients with treatment related adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetic Nephropathy
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Pentoxifylline in Diabetic Kidney Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone in people with Diabetic Nephropathy and Albuminuria, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of oral pirfenidone (1800 mg) in albuminuria (time frame: 12 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 14 Mar 2023.