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

Hypoalbuminemia Clinical Trial

— ICM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00529633
• Other study ID #: 200614929
• Status: Terminated
• Phase: Phase 3
• First received: September 12, 2007
• Last updated: March 6, 2018
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoalbuminemia
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Thalidomide
Thalidomide by mouth at night for a total of 24 weeks

Other:
• Sugar pill
Placebo by mouth at night for a total of 24 weeks

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
George A. Kaysen, M.D.	Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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