The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
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.
Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to
have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with
CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those
with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment
Phase:
Phase 3
Details
Lead Sponsor:
George A. Kaysen, M.D. University of California, Davis