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

NCT00529633 | Terminated Phase 3 Results DMC

• 1 other identifier: 200614929
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoalbuminemia

Keywords

Inflammation; albumin

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Thalidomide

ACTIVE COMPARATOR

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

No Drug

PLACEBO COMPARATOR

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

Interventions

Thalidomide DRUG

Thalidomide by mouth at night for a total of 24 weeks

Thalidomide

Sugar pill OTHER

Placebo by mouth at night for a total of 24 weeks

Also known as: Placebo (no drug)

No Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• George A. Kaysen, M.D.: lead
• Beth Israel Medical Center: collaborator

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Hypoalbuminemia; Inflammation

Interventions

Thalidomide; Sugars

Condition Hierarchy (Ancestors)

Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Limitations and Caveats

Early termination -- Study is terminated due to low enrollment of subjects willing to enter this study

Results Point of Contact

• Title: George Kaysen MD PhD, Principal Investigator
• Organization: University of California, Davis

gakaysen@ucdavis.edu

916-734-3774

Study Officials

• George A Kaysen, MD Ph.D

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• James F. Winchester, MD

  Beth Israel Medicial Center New York New York

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: April 2, 2018
• Results First Posted: October 28, 2016

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)