Clinical trial NCT00529633: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Official title: Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypoalbuminemia
Keywords: Inflammation
albumin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Beth Israel Medical Center
First posted: 2007-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: 4.1 Pre-assignment measurements will include:

1. Patient is eligible for enrollment.
2. Complete physical examination.
3. Blood draw at initiation of hemodialysis session
4. Instruction on birth control methods required.
5. 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.

Eligibility criteria: Inclusion Criteria:

1. End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
2. Serum C reactive protein level of ≥ 0.8 mg/dl.
3. Serum albumin \< 3.8 g/dl (BCG).
4. Signing a written informed consent form.
5. Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
6. Age \> 18 years.

Exclusion Criteria:

1. Pregnant and/ or lactating female.
2. Active infection within the previous 8 weeks requiring administration of antibiotics.
3. Patients receiving systemic immunosuppressive therapy.
4. Patients with HIV.

Primary outcomes:
measure: Difference in Serum Albumin
timeFrame: 28 weeks total
measure: Difference in Serum CRP
timeFrame: 28 weeks total
measure: Difference in Serum Prealbumin
timeFrame: 28 weeks total
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: University of California, Davis
name: George A Kaysen, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medicial Center New York New York
name: James F. Winchester, MD
role: STUDY_DIRECTOR
References: