InflammationPhase 4NCT01269827
Pentoxifylline and Systemic Inflammation in Hemodialysis Patients
A Phase 4 study testing Pentoxifylline and starch tablets in people with Inflammation and End-stage Renal Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammation, End-stage Renal Disease, Hemodialysis
- What is being tested?
- Pentoxifylline and starch tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2006to May 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- ≥2 months on HD,
- arteriovenous fistula as vascular access, and
- endorsement of informed consent.
Who cannot join
- inflammatory cause of ESRD,
- liver disease, cancer, AIDS,
- any infectious disease 2 months before the study,
- failed kidney graft,
- hypersensitivity to PTX or other methylxanthines,
- hemorrhage/clotting disorders,
- risk for worsening pre-existing cardiac arrhythmias or arterial hypotension,
- treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Especialidades, CMNO, IMSS
Guadalajara, Jalisco, 44320
About this study
Official title: Randomized, Double-Blinded, Controlled Clinical Trial of the Effect Pentoxifylline vs Placebo on the Serum Concentrations of TNF-a, IL-6 and CRP of Patients in Hemodialysis
The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis.
Read the detailed description
Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule.
All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details.
Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.
- Conditions
- Inflammation, End-stage Renal Disease, Hemodialysis
- Being tested
- Pentoxifylline, starch tablets
- Keywords
- inflammation, pentoxifylline, hemodialysis
- Medical subject headings
- Inflammation, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called trental
Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)
starch tabletsDrug
Also called placebo
Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline | Experimental | Not described Receives: Drug: Pentoxifylline |
| placebo | Placebo comparator | Not described Receives: Drug: starch tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of TNF-a, IL-6 and CRP
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alfonso Martín Cueto Manzano, Coordinación de Investigación en Salud, Mexico
- Investigators
- Alfonso M. M Cueto-Manzano, MD, MSc, PhD, Study chair, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269827
- Sponsor's protocol ID
- 2006-1A-I-007
- Other IDs
- other grant
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Controlled Clinical Trial of the Effect Pentoxifylline vs Placebo on the Serum Concentrations of TNF-a, IL-6 and CRP of Patients in Hemodialysis
- ClinicalTrials.gov ID
- NCT01269827
- Acronym / sponsor ID
- 2006-1A-I-007
- Conditions
- Inflammation, End-stage Renal Disease, Hemodialysis
- Keywords
- inflammation, pentoxifylline, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Jan 2011 (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.
The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis.
Detailed description
Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule.
All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details.
Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline | Experimental | Drug: Pentoxifylline |
| placebo | Placebo comparator | Drug: starch tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years,
- ≥2 months on HD,
- arteriovenous fistula as vascular access, and
- endorsement of informed consent.
Key exclusion criteria (8 listed)
- inflammatory cause of ESRD,
- liver disease, cancer, AIDS,
- any infectious disease 2 months before the study,
- failed kidney graft,
- hypersensitivity to PTX or other methylxanthines,
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: trentalOver a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time) | Drug | pentoxifylline |
| starch tabletsAlso: placeboOver a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time) | Drug | placebo |
Primary outcome
serum levels of TNF-a, IL-6 and CRP
Time frame: 4 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 19 Dec 2018.
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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.
Alfonso M. M Cueto-Manzano, MD, MSc, PhD study chair
Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, 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 and starch tablets in people with Inflammation and End-stage Renal Disease, run by Coordinación de Investigación en Salud, Mexico 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 4 inclusion and 8 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 19 Dec 2018. 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?
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?
serum levels of TNF-a, IL-6 and CRP (time frame: 4 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 19 Dec 2018.