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

Study Overview
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Brief Summary
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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

Detailed Description
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4.1 Pre-assignment measurements will include: Patient is eligible for enrollment. Complete physical examination. Blood draw at initiation of hemodialysis session Instruction on birth control methods required. 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 4.2 Detailed description of treatment: Patients who completed the first 4 weeks will be randomized into Treatment group. A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to Active Treatment arm will receive Placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. Weekly, Subjects will have blood drawn; will undergo a capsule count to establish a compliance range of > 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy. If somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules). Patients who completed 24 weeks of study will have final evaluation at week 28.

Official Title
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Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients

Conditions
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Hypoalbuminemia

Intervention / Treatment
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* Drug: Thalidomide
* Other: Sugar pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thalidomide<br>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. | Drug: Thalidomide<br>* Thalidomide by mouth at night for a total of 24 weeks<br>|
| Placebo Comparator: No Drug<br>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. | Other: Sugar pill<br>* Placebo by mouth at night for a total of 24 weeks<br>* Other names: Placebo (no drug);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Serum Albumin | Serum albumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety | 28 weeks total | 
| Difference in Serum CRP | Serum CRP in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety | 28 weeks total | 
| Difference in Serum Prealbumin | Serum Prealbumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety | 28 weeks total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, albumin