| City: |
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Brookhaven |
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State:
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MS |
| Zip Code: |
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39601 |
| Conditions: |
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End Stage Renal Disease |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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 ≥ 18,000 and <55,000 units/week of treatment for ≥ 30 days prior to screening
visit;
- Subject's two most recent 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 45 days prior to randomization;
- 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;
- Stable nutrition status with all albumin levels >3.5 g/dL within the prior 90 days.
Exclusion Criteria:
- 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 45 days prior to screening;
- Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular
diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within the past 3 months;
- Significant concurrent liver disorder [Aspartate transaminase (AST) or alanine
transaminase (ALT) values > 3 times upper limit of normal (ULN) within 45 days prior
to screening];
- Platelet count < 130x109 within the last 90 days;
- 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 randomization;
- 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. |
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| Study is available at: |
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Fresenius Medical Care North America
Brookhaven, MS 39601
United States
Primary Contact:
Melanie Haydel, RN
Email: melanie.haydel@fmc-na.com
Phone: 601-833-9720
Secondary Contact:
Christina M Meng, BS, CCRP
Email: christina.meng@fmc-na.com
Phone: 615-345-5542 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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