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Trial record 75 of 359 for:    transthyretin

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

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ClinicalTrials.gov Identifier: NCT00529633
Recruitment Status : Terminated (Low enrollment -- We could not recruit patients willing to be enrolled)
First Posted : September 14, 2007
Results First Posted : October 28, 2016
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
Beth Israel Medical Center
Information provided by (Responsible Party):
George A. Kaysen, M.D., University of California, Davis

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

Condition or disease Intervention/treatment Phase
Hypoalbuminemia Drug: Thalidomide Other: Sugar pill Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Study Start Date : September 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Thalidomide

Arm Intervention/treatment
Active Comparator: Thalidomide
  1. 12 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. 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
Thalidomide by mouth at night for a total of 24 weeks

Placebo Comparator: No Drug
  1. 12 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. Patients will receive Placebo (Sugar pill) for a period of 24 weeks.
Other: Sugar pill
Placebo by mouth at night for a total of 24 weeks
Other Name: Placebo (no drug)




Primary Outcome Measures :
  1. Difference in Serum Albumin [ Time Frame: 28 weeks total ]
    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

  2. Difference in Serum CRP [ Time Frame: 28 weeks total ]
    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

  3. Difference in Serum Prealbumin [ Time Frame: 28 weeks total ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529633


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
George A. Kaysen, M.D.
Beth Israel Medical Center
Investigators
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Principal Investigator: George A Kaysen, MD Ph.D University of California, Davis
Study Director: James F. Winchester, MD Beth Israel Medicial Center New York New York

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Responsible Party: George A. Kaysen, M.D., Professor of Medicine, University of California, Davis
ClinicalTrials.gov Identifier: NCT00529633     History of Changes
Other Study ID Numbers: 200614929
First Posted: September 14, 2007    Key Record Dates
Results First Posted: October 28, 2016
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by George A. Kaysen, M.D., University of California, Davis:
Inflammation
albumin

Additional relevant MeSH terms:
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Hypoalbuminemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents