Trial Outcomes & Findings for Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2 (NCT NCT02278562)
NCT ID: NCT02278562
Last Updated: 2025-02-06
Results Overview
LDR is a sensitive laboratory assessment of amino acid metabolism
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
baseline and 3 months
Results posted on
2025-02-06
Participant Flow
This study was conducted at the VA Nashville and the Vanderbilt University Medical Center between October 2014 and March 2017.
There is about a 2-week screening period between enrollment and assignment to a treatment group to access inclusion/exclusion criteria. Although 33 subjects were enrolled, only 24 subjects were assigned to a treatment group (6 subjects were screen failures and 3 subjects withdrew prior to being randomized).
Participant milestones
| Measure |
Anakinra
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
8
|
|
Overall Study
COMPLETED
|
9
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2
Baseline characteristics by cohort
| Measure |
Anakinra
n=9 Participants
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
n=7 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
n=8 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 17 • n=5 Participants
|
46 years
STANDARD_DEVIATION 15 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 monthsPopulation: The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.
LDR is a sensitive laboratory assessment of amino acid metabolism
Outcome measures
| Measure |
Anakinra
n=9 Participants
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
n=7 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
n=8 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
|---|---|---|---|
|
Change in Leucine Disposal Rate (LDR)
|
-0.011 mg/kg/min
Interval -0.014 to -0.001
|
0.005 mg/kg/min
Interval -0.026 to 0.015
|
0.001 mg/kg/min
Interval -0.008 to 0.008
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.
Whole-body net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the whole body
Outcome measures
| Measure |
Anakinra
n=9 Participants
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
n=7 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
n=8 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
|---|---|---|---|
|
Change in Whole-body Net Protein Balance
|
-0.184 mg/kg/min
Interval -0.311 to -0.011
|
-0.215 mg/kg/min
Interval -0.519 to 0.266
|
0.018 mg/kg/min
Interval -0.2 to 0.123
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.
Skeletal muscle net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the skeletal muscles.
Outcome measures
| Measure |
Anakinra
n=9 Participants
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
n=7 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
n=8 Participants
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
|---|---|---|---|
|
Change in Skeletal Muscle Net Protein Balance
|
-5.1 μg/100 ml/min
Interval -47.9 to 79.2
|
11.8 μg/100 ml/min
Interval -34.7 to 26.6
|
134.1 μg/100 ml/min
Interval 1.8 to 342.5
|
Adverse Events
Anakinra
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Actos
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo 1 and 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anakinra
n=9 participants at risk
100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
|
Actos
n=7 participants at risk
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months
actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
|
Placebo 1 and 2
n=8 participants at risk
Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months
placebo: placebo capsules and injection
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
22.2%
2/9 • Number of events 2 • 3 months
|
0.00%
0/7 • 3 months
|
0.00%
0/8 • 3 months
|
|
General disorders
syncope
|
22.2%
2/9 • Number of events 2 • 3 months
|
0.00%
0/7 • 3 months
|
0.00%
0/8 • 3 months
|
|
General disorders
allergic reaction
|
11.1%
1/9 • Number of events 1 • 3 months
|
0.00%
0/7 • 3 months
|
0.00%
0/8 • 3 months
|
|
Renal and urinary disorders
fluid overload
|
11.1%
1/9 • Number of events 1 • 3 months
|
0.00%
0/7 • 3 months
|
0.00%
0/8 • 3 months
|
|
Renal and urinary disorders
access related
|
0.00%
0/9 • 3 months
|
14.3%
1/7 • Number of events 1 • 3 months
|
0.00%
0/8 • 3 months
|
|
Nervous system disorders
right side weakness
|
0.00%
0/9 • 3 months
|
14.3%
1/7 • Number of events 1 • 3 months
|
0.00%
0/8 • 3 months
|
|
Cardiac disorders
arrhythmia
|
0.00%
0/9 • 3 months
|
14.3%
1/7 • Number of events 1 • 3 months
|
0.00%
0/8 • 3 months
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/9 • 3 months
|
0.00%
0/7 • 3 months
|
12.5%
1/8 • Number of events 1 • 3 months
|
|
Nervous system disorders
seizure
|
0.00%
0/9 • 3 months
|
0.00%
0/7 • 3 months
|
12.5%
1/8 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place