Trial Outcomes & Findings for Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3 (NCT NCT00878969)
NCT ID: NCT00878969
Last Updated: 2016-02-15
Results Overview
IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
78 participants
Primary outcome timeframe
baseline and 18 months
Results posted on
2016-02-15
Participant Flow
This study was conducted at the Vanderbilt University Medical Center and at the University of Washington between January 2010 and June 2015.
There is a 3-week period between enrollment and assignment to treatment group. This "washout" period is to ensure that no blood pressure medicines (ARBs or ACE inhibitors) are left in the body. Although 123 subjects were enrolled, only 78 were assigned to a treatment group (45 subjects were screen failures).
Participant milestones
| Measure |
Valsartan
80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
|
Ramipril
2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
|
Placebo
matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
26
|
|
Overall Study
COMPLETED
|
10
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
11
|
Reasons for withdrawal
| Measure |
Valsartan
80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
|
Ramipril
2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
|
Placebo
matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
5
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
3
|
|
Overall Study
kidney transplant
|
2
|
3
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
Baseline Characteristics
Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3
Baseline characteristics by cohort
| Measure |
Valsartan
n=25 Participants
80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
|
Ramipril
n=27 Participants
2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
|
Placebo
n=26 Participants
matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
53 years
STANDARD_DEVIATION 13 • n=7 Participants
|
49 years
STANDARD_DEVIATION 9 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
26 participants
n=5 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 18 monthsPopulation: Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.
IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.
Outcome measures
Outcome data not reported
Adverse Events
Valsartan
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Ramipril
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan
n=25 participants at risk
80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
|
Ramipril
n=27 participants at risk
2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
|
Placebo
n=26 participants at risk
matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
|
|---|---|---|---|
|
Infections and infestations
infection
|
4.0%
1/25 • Number of events 1 • 18 months
|
11.1%
3/27 • Number of events 5 • 18 months
|
7.7%
2/26 • Number of events 3 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary
|
8.0%
2/25 • Number of events 2 • 18 months
|
11.1%
3/27 • Number of events 3 • 18 months
|
3.8%
1/26 • Number of events 2 • 18 months
|
|
Cardiac disorders
cardiac
|
12.0%
3/25 • Number of events 3 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
3.8%
1/26 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
electroyte disorder
|
4.0%
1/25 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
3.8%
1/26 • Number of events 3 • 18 months
|
|
Vascular disorders
hypertension/hypotension
|
4.0%
1/25 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
7.7%
2/26 • Number of events 3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
0.00%
0/25 • 18 months
|
7.4%
2/27 • Number of events 4 • 18 months
|
0.00%
0/26 • 18 months
|
|
Gastrointestinal disorders
GI upset
|
0.00%
0/25 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
3.8%
1/26 • Number of events 2 • 18 months
|
|
General disorders
generalized symptoms
|
8.0%
2/25 • Number of events 2 • 18 months
|
0.00%
0/27 • 18 months
|
0.00%
0/26 • 18 months
|
|
General disorders
Death
|
0.00%
0/25 • 18 months
|
0.00%
0/27 • 18 months
|
7.7%
2/26 • Number of events 2 • 18 months
|
|
Vascular disorders
access related
|
4.0%
1/25 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
0.00%
0/26 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer
|
4.0%
1/25 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
0.00%
0/26 • 18 months
|
|
General disorders
trauma
|
4.0%
1/25 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
0.00%
0/26 • 18 months
|
|
General disorders
pain
|
0.00%
0/25 • 18 months
|
0.00%
0/27 • 18 months
|
3.8%
1/26 • Number of events 1 • 18 months
|
|
Vascular disorders
blood clot
|
4.0%
1/25 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
0.00%
0/26 • 18 months
|
|
Psychiatric disorders
suicide ideation
|
0.00%
0/25 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
0.00%
0/26 • 18 months
|
|
Vascular disorders
excessive bleeding
|
0.00%
0/25 • 18 months
|
0.00%
0/27 • 18 months
|
3.8%
1/26 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
excessive fluid in abdomen
|
0.00%
0/25 • 18 months
|
0.00%
0/27 • 18 months
|
3.8%
1/26 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Valsartan
n=25 participants at risk
80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
|
Ramipril
n=27 participants at risk
2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
|
Placebo
n=26 participants at risk
matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
|
|---|---|---|---|
|
Vascular disorders
access related
|
32.0%
8/25 • Number of events 12 • 18 months
|
18.5%
5/27 • Number of events 15 • 18 months
|
19.2%
5/26 • Number of events 17 • 18 months
|
|
Gastrointestinal disorders
GI upset
|
8.0%
2/25 • Number of events 4 • 18 months
|
18.5%
5/27 • Number of events 8 • 18 months
|
30.8%
8/26 • Number of events 16 • 18 months
|
|
Cardiac disorders
cardiac
|
16.0%
4/25 • Number of events 7 • 18 months
|
18.5%
5/27 • Number of events 7 • 18 months
|
19.2%
5/26 • Number of events 7 • 18 months
|
|
Nervous system disorders
neurological
|
8.0%
2/25 • Number of events 3 • 18 months
|
7.4%
2/27 • Number of events 11 • 18 months
|
7.7%
2/26 • Number of events 5 • 18 months
|
|
Vascular disorders
hypertension/hypotension
|
24.0%
6/25 • Number of events 6 • 18 months
|
25.9%
7/27 • Number of events 9 • 18 months
|
0.00%
0/26 • 18 months
|
|
Metabolism and nutrition disorders
electrolyte disorder
|
8.0%
2/25 • Number of events 10 • 18 months
|
11.1%
3/27 • Number of events 3 • 18 months
|
7.7%
2/26 • Number of events 2 • 18 months
|
|
General disorders
pain
|
12.0%
3/25 • Number of events 4 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
15.4%
4/26 • Number of events 8 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary
|
8.0%
2/25 • Number of events 2 • 18 months
|
18.5%
5/27 • Number of events 5 • 18 months
|
11.5%
3/26 • Number of events 3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
12.0%
3/25 • Number of events 5 • 18 months
|
0.00%
0/27 • 18 months
|
15.4%
4/26 • Number of events 4 • 18 months
|
|
Infections and infestations
infection
|
16.0%
4/25 • Number of events 4 • 18 months
|
0.00%
0/27 • 18 months
|
11.5%
3/26 • Number of events 4 • 18 months
|
|
General disorders
generalized symptoms
|
8.0%
2/25 • Number of events 2 • 18 months
|
18.5%
5/27 • Number of events 6 • 18 months
|
0.00%
0/26 • 18 months
|
|
General disorders
trauma
|
8.0%
2/25 • Number of events 2 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
0.00%
0/26 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place