Trial Outcomes & Findings for The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients (NCT NCT00529633)
NCT ID: NCT00529633
Last Updated: 2018-04-02
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
28 weeks total
Results posted on
2018-04-02
Participant Flow
The study has been terminated due to lack of participation. We enrolled 16 subjects according to eligibility. 4 subjects randomized into the study. Two subjects completed the study.
Subject enrollment into the "active" study must meet capsule count of \>85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program
Participant milestones
| Measure |
Placebo
This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.
Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of \>85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program
|
Thalidomide
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. Patients will receive Thalidomide for a period of 24 weeks.
5. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP
Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.
Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of \>85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program
|
Thalidomide
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. Patients will receive Thalidomide for a period of 24 weeks.
5. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP
Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Thalidomide
n=2 Participants
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 Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid
|
Placebo
n=2 Participants
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 for a period of 24 weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeks totalSerum 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
Outcome measures
| Measure |
Thalidomide
n=1 Participants
This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
|
Placebo
n=1 Participants
Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
|
|---|---|---|
|
Difference in Serum Albumin
week 1
|
3.4 g/dL of Albumin
|
3.7 g/dL of Albumin
|
|
Difference in Serum Albumin
week 2
|
3.7 g/dL of Albumin
|
3.5 g/dL of Albumin
|
|
Difference in Serum Albumin
week 3
|
3.5 g/dL of Albumin
|
3.4 g/dL of Albumin
|
|
Difference in Serum Albumin
week 4
|
3.6 g/dL of Albumin
|
4.0 g/dL of Albumin
|
|
Difference in Serum Albumin
week 8
|
3.8 g/dL of Albumin
|
3.6 g/dL of Albumin
|
|
Difference in Serum Albumin
week 12
|
3.6 g/dL of Albumin
|
4.1 g/dL of Albumin
|
|
Difference in Serum Albumin
week 16
|
3.5 g/dL of Albumin
|
4.0 g/dL of Albumin
|
|
Difference in Serum Albumin
week 20
|
2.9 g/dL of Albumin
|
3.8 g/dL of Albumin
|
|
Difference in Serum Albumin
week 24
|
3.6 g/dL of Albumin
|
3.9 g/dL of Albumin
|
|
Difference in Serum Albumin
week 28
|
3.5 g/dL of Albumin
|
3.9 g/dL of Albumin
|
PRIMARY outcome
Timeframe: 28 weeks totalSerum 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
Outcome measures
| Measure |
Thalidomide
n=1 Participants
This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
|
Placebo
n=1 Participants
Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
|
|---|---|---|
|
Difference in Serum CRP
week 1
|
NA Mg/L CRP
Observation below quantifiable range
|
1.76 Mg/L CRP
|
|
Difference in Serum CRP
week 2
|
NA Mg/L CRP
Observation above quantifiable range
|
2.07 Mg/L CRP
|
|
Difference in Serum CRP
week 3
|
NA Mg/L CRP
Observation below quantifiable range
|
1.76 Mg/L CRP
|
|
Difference in Serum CRP
week 4
|
NA Mg/L CRP
Observation below quantifiable range
|
2.29 Mg/L CRP
|
|
Difference in Serum CRP
week 8
|
NA Mg/L CRP
Observation below quantifiable range
|
2.87 Mg/L CRP
|
|
Difference in Serum CRP
week 12
|
NA Mg/L CRP
Observation above quantifiable range
|
2.87 Mg/L CRP
|
|
Difference in Serum CRP
week 16
|
NA Mg/L CRP
Observation below quantifiable range
|
3.41 Mg/L CRP
|
|
Difference in Serum CRP
week 20
|
NA Mg/L CRP
Observation above quantifiable range
|
1.92 Mg/L CRP
|
|
Difference in Serum CRP
week 24
|
NA Mg/L CRP
Observation above quantifiable range
|
6.01 Mg/L CRP
|
|
Difference in Serum CRP
week 28
|
NA Mg/L CRP
Observation below quantifiable range
|
3.93 Mg/L CRP
|
PRIMARY outcome
Timeframe: 28 weeks totalPopulation: Participant data is not available due to no shipping of specimen to analyzing laboratory
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
Outcome measures
Outcome data not reported
Adverse Events
Thalidomide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Kaysen MD PhD, Principal Investigator
University of California, Davis
Phone: 916-734-3774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place