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Sponsored by: |
University of California, Davis |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00529633 |
Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. The researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients.
Condition | Intervention | Phase |
---|---|---|
Hypoalbuminemia |
Drug: thalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients |
Estimated Enrollment: | 24 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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Treatment: Experimental
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Drug: thalidomide
100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks
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Control: Sham Comparator
This arm will consist of 12 hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
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Drug: thalidomide
100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks
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4.0 TREATMENT PLAN
4.1 Pretreatment measurements will include:
4.2 Detailed description of treatment
A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to receive thalidomide will be given 100 mg (two 50 mg active capsules) to take HS. Subjects will have blood drawn weekly during the first 4 weeks. At each of these visits, the patients who are in the active drug arm will undergo a capsule count to establish a compliance range of > 85%. Subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the S.T.E.P.S.® program will be immediately discontinued from the study and followed for an additional 4 weeks. Subjects who are compliant within 85% of medication and are fully compliant with birth control measures will be further studied.
At the end of the 4th week, drug subjects will again be examined with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy. Compliance will again be assessed.
If somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules). Blood will be drawn again on the 8th week and the patient will be examined again with attention to the skin and peripheral nervous system. Compliance with both contraceptive requirements and with regard to drug use will be established at each visit. Blood will be drawn every 4 weeks after the start of drug for a total of 24 weeks from initiation of drug. Subjects will have a limited physical examination monthly after the first month.
Patients will remain on study for an additional 4 weeks and will have final evaluation at week 28 which will include a blood draw.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James F Winchester, MD | 212-420-4602 | jwinches@bethisraelny.org |
Contact: George A Kaysen, MD Ph.D | 53--752-2970 | gakaysen@ucdavis.edu |
United States, New York | |
Beth Israel Medical Center | Recruiting |
New York, New York, United States, 10003 | |
Contact: James f |
Principal Investigator: | George A Kaysen, MD Ph.D | University of California, Davis |
Study Director: | James F. Winchester, MD | Beth Israel Medicial Center New York New York |
Study ID Numbers: | 200614929-1 |
Study First Received: | September 12, 2007 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00529633 |
Health Authority: | United States: Food and Drug Administration |
Inflammation C reactive protein prealbumin albumin |
Systemic Inflammatory Response Syndrome Thalidomide Shock Hematologic Diseases |
Blood Protein Disorders Hypoalbuminemia Inflammation |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions |
Hypoproteinemia Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |