Trial Outcomes & Findings for Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis (NCT NCT00732069)
NCT ID: NCT00732069
Last Updated: 2013-07-02
Results Overview
Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
During dialysis after one week of study drug
Results posted on
2013-07-02
Participant Flow
Recruitment started in September 2008 and ended in January 2010 in Vanderbilt outpatients Dialysis Center.
Three consented participants were excluded because of hyperkalemia, hypotension and uncontrollable hypertension.They were enrolled but did not start medication and were considered screen failures. The participants required a washout period from either an agiotensin receptor blocker or an angiotensin converting enzyme inhibitor.
Participant milestones
| Measure |
Placebo, Then Ramipril, Then Valsartan
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Placebo, Valsartan, Then Ramipril
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Ramipril, Then Placebo, Then Valsartan
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Valsartan, Then Placebo, Then Ramipril
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Ramipril, Valsartan, Then Placebo
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Valsartan, Ramipril, Then Placebo
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
|---|---|---|---|---|---|---|
|
First Study Drug
STARTED
|
3
|
3
|
3
|
2
|
3
|
2
|
|
First Study Drug
COMPLETED
|
3
|
3
|
3
|
2
|
3
|
2
|
|
First Study Drug
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout After First Study Drug
STARTED
|
3
|
3
|
3
|
2
|
3
|
2
|
|
Washout After First Study Drug
COMPLETED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Washout After First Study Drug
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Second Study Drug
STARTED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Second Study Drug
COMPLETED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Second Study Drug
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout After Second Study Drug
STARTED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Washout After Second Study Drug
COMPLETED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Washout After Second Study Drug
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Study Drug
STARTED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Third Study Drug
COMPLETED
|
2
|
3
|
3
|
2
|
3
|
2
|
|
Third Study Drug
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo, Then Ramipril, Then Valsartan
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Placebo, Valsartan, Then Ramipril
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Ramipril, Then Placebo, Then Valsartan
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Valsartan, Then Placebo, Then Ramipril
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Ramipril, Valsartan, Then Placebo
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
Valsartan, Ramipril, Then Placebo
Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
|
|---|---|---|---|---|---|---|
|
Washout After First Study Drug
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=16 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
50.5 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During dialysis after one week of study drugPopulation: All participants who completed the three arm treatment.
Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo
Outcome measures
| Measure |
Ramipril
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
Valsartan
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
Placebo
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
|---|---|---|---|
|
Interleukin 1 Beta
|
6.18 pg/mL
Standard Error 3.56
|
2.16 pg/mL
Standard Error 2.16
|
1.44 pg/mL
Standard Error 1.49
|
SECONDARY outcome
Timeframe: During dialysis after one week of study drugMean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo
Outcome measures
| Measure |
Ramipril
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
Valsartan
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
Placebo
n=15 Participants
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
|---|---|---|---|
|
F2-Isoprostanes
|
59.55 pg/mL
Standard Error 27.53
|
59.03 pg/mL
Standard Error 29.39
|
50.23 pg/mL
Standard Error 22.59
|
Adverse Events
Ramipril
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Valsartan
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramipril
n=15 participants at risk
All subjects receiving ramipril
|
Valsartan
n=15 participants at risk
All subjects receiving valsartan
|
Placebo
n=15 participants at risk；n=16 participants at risk
All subjects receiving placebo
|
|---|---|---|---|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.2%
1/16 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Ramipril
n=15 participants at risk
All subjects receiving ramipril
|
Valsartan
n=15 participants at risk
All subjects receiving valsartan
|
Placebo
n=15 participants at risk；n=16 participants at risk
All subjects receiving placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest pain not cardiac
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Bruising after falling
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Vascular disorders
Vascular acces complication
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place