Chronic Kidney Disease stage3 and 4Phase 4PENFOSIDINENCT03664414
Pentoxifylline Effect in Patients With Diabetic Nephropathy.(PENFOSIDINE STUDY)
A Phase 4 study testing pentoxifylline in people with Chronic Kidney Disease stage3 and 4 and Type 2 Diabetes Mellitus, run by Maria Eugenia Galván Plata at 1 site in Mexico.
Trial summary
One of the purposes of the management of the patient with chronic kidney disease (CKD)is to slow the decline of renal function. The mechanisms by which the renal function declines involve inflammatory and fibrotic responses due in part by the effects of oxidative stress. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Kidney Disease stage3 and 4, Type 2 Diabetes Mellitus
- What is being tested?
- pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2018to 31 Dec 2021
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD
- Type 2 diabetes mellitus
- Microalbuminuria
- Proteinuria.
- Creatinine plasma clearance ˂ of 60 mL / min.
Who cannot join
- History of psychiatric disorders,
- Immunosuppressants treatment
- Herbalism Treatment
- History of chronic alcoholism.
- Type 1 diabetes mellitus.
- Chronic obstructive pulmonary disease.
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- Pulmonary fibrosis
- Heart failure
- HIV-AIDS.
- Liver cirrhosis.
- Chronic hepatitis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Cibimi - Hgz 83 Imss
Morelia, Michoacán, 58290
Oliva Mejía - Rodríguez, PhD, 01 4431853008, oliva.mejia@imss.gob.mx
About this study
Official title: Pentoxifylline Effect on Renal Function, Oxidative Stress, Inflammation, and Fibrosis Markers, and Quality of Life in Patients With Diabetic Nephropathy
One of the purposes of the management of the patient with chronic kidney disease (CKD)is to slow the decline of renal function. The mechanisms by which the renal function declines involve inflammatory and fibrotic responses due in part by the effects of oxidative stress. Pentoxifylline (PTX)is a drug that stimulates adenosine receptors, and produces inhibition of phosphodiesterases, as well as being a dopaminergic modulator through D1 and D2 receptors. Its main effects are inhibition of the inflammatory state by decreasing serum levels of tumor necrosis factor alpha (TNF-ɒ) and monocyte chemo attractant protein 1 (MCP_1), which may slow down the decline of renal function. It also produces diminish of sympathetic activity, with the reduction of circulating levels of norepinephrine (NA), which may contribute to the reduction of glomerulosclerosis in diabetic patients. In the connective tissue increases the activity of the collagenases and decrease of collagen, fibronectin and glucosamine of the fibroblasts as well as inhibition of oxygen free radicals. Due to its antioxidant, anti-inflammatory and anti-fibrotic effects, PTX can result in an excellent therapeutic option for the prevention of CKD in DM2.
This work proposes the use of pentoxifylline as treatment CKD in DM2. Its application in patients with CKD will allow a therapeutic management with different targets, for its antioxidant, anti-inflammatory and antifibrotic effects that will be evaluated by means of fibrosis, inflammation and oxidative stress markers. The results will be of great importance in clinical practice, since they will justify the use of a new pharmacological tool, already known, with minimal adverse effects and low cost, accessible to all strata of the population since it is found as generic.
Read the detailed description
Patients will be randomly selected from the outpatient family medicine clinics. Once included, patients will be randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 2 years, patients of the study group will receive one PTX tablet (400 mg) orally three times a day (at dinner time), whereas controls will receive one cellulose identical tablet on the same schedule.
All patients will continue with their usual treatment prescribed by their family doctor. Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every six months up to 24 months, for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, electrolytes, liver function tests, serum total proteins, (will be measure by usual methods). In serum samples at 0, 6, 12, 18 and 24 months, high sensibility C reactive protein will be measured by nephelometry, Brain natriuretic peptide and Serum Cystatin C will be measured by ELISA. Glomerular filtration rate (GFR) will be calculated based in Cystatin C level Grubb's equations. Vitamin C will be measured by HPLC. A 24 h ambulatory blood pressure monitoring (24 h ABPM), M-mode and two-dimensional echocardiographic, and an analysis of body composition by bioelectrical impedance will be done at baseline 6, 12, 18 and 24 months. To investigate health-related quality of life the short-form 36 (SF-36) questionnaire will be applied. Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit and by the Morinsky Green test.
- Being tested
- pentoxifylline
- Keywords
- oxidative stress, fibrosis, inflammation, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifyllineDrug
Also called Trental
Pentoxifylline or placebo will be prescribed three times a day with meals. All the participants will continue with the usual treatment. Time frame: two years
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo group will receive 1 tablet of cellulose pill to mimic pentoxifylline tablets three times a day with meals, during the following two years. Receives: Drug: pentoxifylline |
| Pentoxifylline group | Active comparator | Pentoxifillyne or experimental group will receive 400 mg of pentoxifylline three times a day with meals, during the following two years. Receives: Drug: pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the glomerular filtration rate
It will be measure as to duplicate serum creatinine levels from baseline (mg/dL), or to pass from a stage of chronic kidney disease to he next stage (GFR mL/min)
Measured: The measurements will be done baseline and every six months up to 24 months.
Secondary outcomes (4)
Change in oxidative stress marker.
The change in vit C level from baseline (normal range 4-8.8mg/ L)
Measured: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in fibrosis markers.
Change in Nt_ProBNP from the baseline (Normal values up to 381 pg/mL)
Measured: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in inflammation markers.
To assess inflammation high sensitivity C reactive protein will be measured by nephelometry. (normal value < 5 mg/L
Measured: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in health-related quality of life
This outcome will be measured by the SF 36 questionnaire, themaximun punctuation is 100, as greater punctuation a better quality of life
Measured: The questionnaire will be applied baseline and every six months up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Mar 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3 and 4Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- blinded,multicenter, randomized, pentoxifylline vs placebo controlled clinical trial. Time: two years after the enrollment of the last patient.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Eugenia Galván Plata
- Sponsor type
- Other government
- Collaborators
- Centro de Investigación Biomédica de Michoacán., Hospital General Regional N° 1 Instituto Mexicano del Seguro Social., Hospital General de Zona N° 83 Instituto Mexicano del Seguro Social., Coordinación Auxiliar Medica de Investigación en Salud. Delegación Michoacán.
- Responsible party
- Sponsor-investigator, Maria Eugenia Galván Plata, Coordinación de Investigación en Salud, Mexico
- Investigators
- Oliva Mejía-Rodríguez, PhD, Principal investigator, CIBIMI IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664414
- Sponsor's protocol ID
- CNIC-2015-785-065
- Acronym
- PENFOSIDINE
- Status last verified
- Feb 2019
- First submitted
- 25 Jul 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline Effect on Renal Function, Oxidative Stress, Inflammation, and Fibrosis Markers, and Quality of Life in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03664414
- Acronym / sponsor ID
- PENFOSIDINE / CNIC-2015-785-065
- Keywords
- oxidative stress, fibrosis, inflammation, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Maria Eugenia Galván PlataOther government
- Collaborators
- Centro de Investigación Biomédica de Michoacán., Hospital General Regional N° 1 Instituto Mexicano del Seguro Social., Hospital General de Zona N° 83 Instituto Mexicano del Seguro Social., Coordinación Auxiliar Medica de Investigación en Salud. Delegación Michoacán.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Sep 2018 (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.
One of the purposes of the management of the patient with chronic kidney disease (CKD)is to slow the decline of renal function. The mechanisms by which the renal function declines involve inflammatory and fibrotic responses due in part by the effects of oxidative stress. Pentoxifylline (PTX)is a drug that stimulates adenosine receptors, and produces inhibition of phosphodiesterases, as well as being a dopaminergic modulator through D1 and D2 receptors. Its main effects are inhibition of the inflammatory state by decreasing serum levels of tumor necrosis factor alpha (TNF-ɒ) and monocyte chemo attractant protein 1 (MCP_1), which may slow down the decline of renal function. It also produces diminish of sympathetic activity, with the reduction of circulating levels of norepinephrine (NA), which may contribute to the reduction of glomerulosclerosis in diabetic patients. In the connective tissue increases the activity of the collagenases and decrease of collagen, fibronectin and glucosamine of the fibroblasts as well as inhibition of oxygen free radicals. Due to its antioxidant, anti-inflammatory and anti-fibrotic effects, PTX can result in an excellent therapeutic option for the prevention of CKD in DM2.
This work proposes the use of pentoxifylline as treatment CKD in DM2. Its application in patients with CKD will allow a therapeutic management with different targets, for its antioxidant, anti-inflammatory and antifibrotic effects that will be evaluated by means of fibrosis, inflammation and oxidative stress markers. The results will be of great importance in clinical practice, since they will justify the use of a new pharmacological tool, already known, with minimal adverse effects and low cost, accessible to all strata of the population since it is found as generic.
Detailed description
Patients will be randomly selected from the outpatient family medicine clinics. Once included, patients will be randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 2 years, patients of the study group will receive one PTX tablet (400 mg) orally three times a day (at dinner time), whereas controls will receive one cellulose identical tablet on the same schedule.
All patients will continue with their usual treatment prescribed by their family doctor. Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every six months up to 24 months, for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, electrolytes, liver function tests, serum total proteins, (will be measure by usual methods). In serum samples at 0, 6, 12, 18 and 24 months, high sensibility C reactive protein will be measured by nephelometry, Brain natriuretic peptide and Serum Cystatin C will be measured by ELISA. Glomerular filtration rate (GFR) will be calculated based in Cystatin C level Grubb's equations. Vitamin C will be measured by HPLC. A 24 h ambulatory blood pressure monitoring (24 h ABPM), M-mode and two-dimensional echocardiographic, and an analysis of body composition by bioelectrical impedance will be done at baseline 6, 12, 18 and 24 months. To investigate health-related quality of life the short-form 36 (SF-36) questionnaire will be applied. Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit and by the Morinsky Green test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- blinded,multicenter, randomized, pentoxifylline vs placebo controlled clinical trial. Time: two years after the enrollment of the last patient.
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: pentoxifyllinePlacebo group will receive 1 tablet of cellulose pill to mimic pentoxifylline tablets three times a day with meals, during the following two years. |
| Pentoxifylline group | Active comparator | Drug: pentoxifyllinePentoxifillyne or experimental group will receive 400 mg of pentoxifylline three times a day with meals, during the following two years. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CKD
- Type 2 diabetes mellitus
- Microalbuminuria
- Proteinuria.
- Creatinine plasma clearance ˂ of 60 mL / min.
Key exclusion criteria (11 listed)
- History of psychiatric disorders,
- Immunosuppressants treatment
- Herbalism Treatment
- History of chronic alcoholism.
- Type 1 diabetes mellitus.
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 |
|---|---|---|
| pentoxifyllineAlso: TrentalPentoxifylline or placebo will be prescribed three times a day with meals. All the participants will continue with the usual treatment. Time frame: two years | Drug | Pentoxifylline group, Placebo group |
Primary outcome
Change in the glomerular filtration rate
Time frame: The measurements will be done baseline and every six months up to 24 months.
It will be measure as to duplicate serum creatinine levels from baseline (mg/dL), or to pass from a stage of chronic kidney disease to he next stage (GFR mL/min)
4 secondary outcomes
Change in oxidative stress marker.
Time frame: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in fibrosis markers.
Time frame: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in inflammation markers.
Time frame: Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.
Change in health-related quality of life
Time frame: The questionnaire will be applied baseline and every six months up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Yes. The individual participant data for all primary and secondary outcome measures will be made available
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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.
Oliva Mejía-Rodríguez, PhD principal investigator
CIBIMI IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pentoxifylline in people with Chronic Kidney Disease stage3 and 4 and Type 2 Diabetes Mellitus, run by Maria Eugenia Galván Plata 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 5 inclusion and 11 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 7 Feb 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Maria Eugenia Galván Plata, M. D (+015556276900 ext. 21230, eugenia.galvan@imss.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the glomerular filtration rate (time frame: The measurements will be done baseline and every six months up to 24 months.). 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 7 Feb 2019.