The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients (ICM)
Hypoalbuminemia
About this trial
This is an interventional treatment trial for Hypoalbuminemia focused on measuring Inflammation, albumin
Eligibility Criteria
Inclusion Criteria:
- End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
- Serum C reactive protein level of ≥ 0.8 mg/dl.
- Serum albumin < 3.8 g/dl (BCG).
- Signing a written informed consent form.
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
- Age > 18 years.
Exclusion Criteria:
- Pregnant and/ or lactating female.
- Active infection within the previous 8 weeks requiring administration of antibiotics.
- Patients receiving systemic immunosuppressive therapy.
- Patients with HIV.
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Thalidomide
No Drug
12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months Serum C reactive protein level of ≥ 0.8 mg/dl Serum albumin < 3.8 g/dl (BCG) Patients will receive 100mg Thalidomide for a period of 4 weeks; if somnolence tolerated, dosage is increased to 200mg nightly for a period of 20 more weeks -- to total of 24 weeks on Thalidomide.
12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months Serum C reactive protein level of ≥ 0.8 mg/dl Serum albumin < 3.8 g/dl (BCG) Patients will receive Placebo (Sugar pill) for a period of 24 weeks.