Trial Outcomes & Findings for A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease (NCT NCT04072432)
NCT ID: NCT04072432
Last Updated: 2024-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
24 hours post-infusion
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
120 mg
Single IV infusion
|
240 mg
Single IV infusion
|
360 mg
Single IV infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
120 mg
n=6 Participants
Single IV infusion
|
240 mg
n=6 Participants
Single IV infusion
|
360 mg
n=6 Participants
Single IV infusion
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 14.87 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 11.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 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
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-infusionOutcome measures
| Measure |
120 mg
n=6 Participants
Single IV infusion
|
240 mg
n=6 Participants
Single IV infusion
|
360 mg
n=6 Participants
Single IV infusion
|
|---|---|---|---|
|
Effect of RBT-3 on Plasma Ferritin Levels
|
2.49 Ratio (24 h post-infusion over baseline)
Interval 1.94 to 3.19
|
4.42 Ratio (24 h post-infusion over baseline)
Interval 3.45 to 5.66
|
4.90 Ratio (24 h post-infusion over baseline)
Interval 3.82 to 6.28
|
PRIMARY outcome
Timeframe: 24 hours post-infusionOutcome measures
| Measure |
120 mg
n=6 Participants
Single IV infusion
|
240 mg
n=6 Participants
Single IV infusion
|
360 mg
n=6 Participants
Single IV infusion
|
|---|---|---|---|
|
Effect of RBT-3 on Plasma HO-1 Levels
|
0.0171 Ratio (24 h post-infusion over baseline)
Interval -0.694 to 0.728
|
-0.7086 Ratio (24 h post-infusion over baseline)
Interval -1.419 to 0.002
|
-0.0641 Ratio (24 h post-infusion over baseline)
Interval -0.775 to 0.646
|
Adverse Events
120 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
240 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
360 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
120 mg
n=6 participants at risk
Single IV infusion
|
240 mg
n=6 participants at risk
Single IV infusion
|
360 mg
n=6 participants at risk
Single IV infusion
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mild Congestion
|
0.00%
0/6 • 8 days
|
0.00%
0/6 • 8 days
|
16.7%
1/6 • Number of events 1 • 8 days
|
Additional Information
Stacey Ruiz, PhD / VP, Drug Development
Renibus Therapeutics
Phone: 424-209-2734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place