End Stage Renal DiseasePhase 2NCT01102218
A Safety Study of Pentoxifylline for the Treatment of Anemia
A Phase 2 study testing Erythropoietin and Pentoxifylline in people with End Stage Renal Disease, run by Fresenius Medical Care North America at 10 sites in United States.
Trial summary
Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease. Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown promise in improving the treatment of patients with anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Erythropoietin and Pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2010to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years;
- Able to comply with the study procedures and medication;
- Written informed consent given;
- On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to screening;
- Subject must have been on a stable (< 25% change) erythropoietin dose with an average of ≥ 15,000 and <55,000 units/week of treatment for ≥ 14 days prior to screening visit;
- Two hemoglobin measurements must meet the following criteria: (1) Taken ≥ 2 weeks apart; (2) Between 10 and 12 g/dL, inclusive; (3) Within 1 g/dL of each other; and (4) Occurred within 30 days prior to screening visit;
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- If subject is a female and of childbearing potential (pre-menopausal and not surgically sterile), subject is willing to use an effective contraceptive method throughout study, which includes abstinence, barrier methods, hormones, or IUDs;
- Life expectancy of 12 months or greater;
- Most recent single pool Kt/V ≥1.2, taken within 45 days prior to screening visit;
- Stable nutrition status with all albumin levels ≥ 3.0 g/dL within the 30 days prior to screening visit.
Who cannot join
- Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit;
- Currently undergoing nocturnal hemodialysis;
- A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
- Serum iPTH > 800 pg/mL within 90 days prior to screening visit;
- Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to screening visit;
- Significant concurrent liver disorder [Aspartate transaminase (AST) or alanine transaminase (ALT) values > 3 times upper limit of normal (ULN) within 30 days prior to screening];
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- Platelet count < 130x109 within 30 days prior to screening visit or on the day of the screening visit;
- Known hypersensitivity to, or intolerance of, Pentoxifylline or other methylxanthines, such as caffeine, theophylline or theobromine;
- Currently taking pentoxifylline, warfarin, theophylline, aminophylline, dyphylline, or oxtriphylline;
- Absolute or functional iron deficiency [transferrin saturation (TSAT) <20%] within 45 days prior to screening;
- Recent or severe hemorrhage per PI discretion;
- Significant bleeding episode or prolonged bleeding from dialysis access per PI judgment within the 3 months prior to screening;
- Melatonin treatment, androgen therapy or blood transfusion within 30 days prior to screening;
- Vitamin C therapy at dose greater than 100 mg/day or at a dose which has changed within the last 3 months;
- Current active cancer (excluding basal cell carcinoma of the skin);
- Poorly controlled hypertension per PI judgment within 4 weeks prior to screening;
- Known HIV positive status;
- Significant GI disorders where absorption of an oral medication might, in the opinion of the Investigator, be impaired;
- Anticipated live donor kidney transplant or any other planned major surgery over the study duration;
- History of poor adherence to hemodialysis or medical regimen;
- Any active clinically significant infection or evidence of an underlying infection;
- Currently on immunosuppressive drug regimen other than a stable, low dose of steroids, per PI judgment;
- Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Fresenius Medical Care North America
Brookhaven, Mississippi, 39601
Fresenius Medical Care North America
Chicago, Illinois, 60616
Fresenius Medical Care North America
City of Saint Peters, Missouri, 63376
Fresenius Medical Care North America
Columbia, Tennessee, 38478
Fresenius Medical Care North America
Irving, Texas, 75039
Fresenius Medical Care North America
Kalamazoo, Michigan, 49007
Fresenius Medical Care North America
Las Vegas, Nevada, 89120
Fresenius Medical Care North America
Saint Ann, Missouri, 63074
Fresenius Medical Care North America
Tupelo, Mississippi, 38801
Fresenius Medical Care North America
Tyler, Texas, 75701
About this study
Official title: A Randomized Multi-Center Study to Determine the Safety and Efficacy of Erythropoietin Plus Pentoxifylline Versus Erythropoietin Alone for the Treatment of Anemia in Subjects With End Stage Renal Disease on Maintenance Hemodialysis
Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease.
Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown promise in improving the treatment of patients with anemia. This study will examine the use of pentoxifylline for the treatment of anemia in chronic kidney disease.
Read the detailed description
Treatment of the anemia of renal failure has been revolutionized by the use of erythropoietin and other ESAs (erythropoiesis-stimulating agent). Concerns with ESA use include a substantial number of End Stage Renal Disease (ESRD) patients with ESA-resistant anemia, and a growing body of evidence of potential negative effects of high doses of ESA use, including increased mortality and increased rate of tumor growth in cancer patients.
There are only a couple of small studies in the literature examining the effects of pentoxifylline on anemia in patients with renal failure. The results are limited by the very small number of patients. There is clearly a need for a larger, prospective, clinical trial of pentoxifylline in ESRD patients, not limited to those with ESA-resistant anemia. This would be the first prospective, randomized clinical trial of this size to study pentoxifylline for the treatment of anemia in chronic kidney disease.
- Conditions
- End Stage Renal Disease
- Being tested
- Erythropoietin, Pentoxifylline
- Keywords
- Anemia, ESRD
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Standard of Care
ErythropoietinDrug
Standard of Care
PentoxifyllineDrug
Also called brand name is Trental
400 mg qd po for 6 months
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin plus pentoxifylline | Experimental | Not described Receives: Drug: Erythropoietin; Drug: Pentoxifylline |
| erythropoietin alone | Active comparator | Not described Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erythropoietin Dose
Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
Measured: Baseline and 6 months
Secondary outcomes (2)
Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time
Measured: 6 months
Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Lack of statistical difference between both arms of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond M. Hakim, MD, PhD, Principal investigator, Fresenius Medical Care North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102218
- Sponsor's protocol ID
- 2010-01
- Status last verified
- Mar 2012
- First submitted
- 9 Apr 2010
- Last updated
- 28 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-Center Study to Determine the Safety and Efficacy of Erythropoietin Plus Pentoxifylline Versus Erythropoietin Alone for the Treatment of Anemia in Subjects With End Stage Renal Disease on Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT01102218
- Acronym / sponsor ID
- 2010-01
- Conditions
- End Stage Renal Disease
- Keywords
- Anemia, ESRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of statistical difference between both arms of the trial.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease.
Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown promise in improving the treatment of patients with anemia. This study will examine the use of pentoxifylline for the treatment of anemia in chronic kidney disease.
Detailed description
Treatment of the anemia of renal failure has been revolutionized by the use of erythropoietin and other ESAs (erythropoiesis-stimulating agent). Concerns with ESA use include a substantial number of End Stage Renal Disease (ESRD) patients with ESA-resistant anemia, and a growing body of evidence of potential negative effects of high doses of ESA use, including increased mortality and increased rate of tumor growth in cancer patients.
There are only a couple of small studies in the literature examining the effects of pentoxifylline on anemia in patients with renal failure. The results are limited by the very small number of patients. There is clearly a need for a larger, prospective, clinical trial of pentoxifylline in ESRD patients, not limited to those with ESA-resistant anemia. This would be the first prospective, randomized clinical trial of this size to study pentoxifylline for the treatment of anemia in chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythropoietin plus pentoxifylline | Experimental | Drug: Erythropoietin, Drug: Pentoxifylline |
| erythropoietin alone | Active comparator | Drug: Erythropoietin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged ≥18 years;
- Able to comply with the study procedures and medication;
- Written informed consent given;
- On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to screening;
- Subject must have been on a stable (< 25% change) erythropoietin dose with an average of ≥ 15,000 and <55,000 units/week of treatment for ≥ 14 days prior to screening visit;
Key exclusion criteria (23 listed)
- Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit;
- Currently undergoing nocturnal hemodialysis;
- A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
- Serum iPTH > 800 pg/mL within 90 days prior to screening visit;
- Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to screening visit;
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 |
|---|---|---|
| ErythropoietinStandard of Care | Drug | erythropoietin plus pentoxifylline |
| ErythropoietinStandard of Care | Drug | erythropoietin alone |
| PentoxifyllineAlso: brand name is Trental400 mg qd po for 6 months | Drug | erythropoietin plus pentoxifylline |
Primary outcome
Change in Erythropoietin Dose
Time frame: Baseline and 6 months
Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
2 secondary outcomes
Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time
Time frame: 6 months
Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raymond M. Hakim, MD, PhD principal investigator
Fresenius Medical Care North America
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erythropoietin and Pentoxifylline in people with End Stage Renal Disease, run by Fresenius Medical Care North America at 10 sites in United States.
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 10 inclusion and 23 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: stopped early, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Erythropoietin Dose (time frame: Baseline and 6 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 28 Mar 2012.