drugset / Trial / NCT00529633

The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients

NCT00529633

RandomizedSingle-groupSingle-blindTreatment

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

Timeline

Start
2007-09
Primary completion
2008-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thalidomide Other / unclassified 200 mg Oral