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

Primary Purpose

Hypoalbuminemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sugar pill
Sponsored by
George A. Kaysen, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoalbuminemia focused on measuring Inflammation, albumin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Thalidomide

No Drug

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2007
Last Updated
March 6, 2018
Sponsor
George A. Kaysen, M.D.
Collaborators
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00529633
Brief Title
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Acronym
ICM
Official Title
Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment -- We could not recruit patients willing to be enrolled
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
George A. Kaysen, M.D.
Collaborators
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoalbuminemia
Keywords
Inflammation, albumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thalidomide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Drug
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide by mouth at night for a total of 24 weeks
Intervention Type
Other
Intervention Name(s)
Sugar pill
Other Intervention Name(s)
Placebo (no drug)
Intervention Description
Placebo by mouth at night for a total of 24 weeks
Primary Outcome Measure Information:
Title
Difference in Serum Albumin
Description
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
Time Frame
28 weeks total
Title
Difference in Serum CRP
Description
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
Time Frame
28 weeks total
Title
Difference in Serum Prealbumin
Description
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
Time Frame
28 weeks total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Kaysen, MD Ph.D
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James F. Winchester, MD
Organizational Affiliation
Beth Israel Medicial Center New York New York
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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