Trial Outcomes & Findings for A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease (NCT NCT04072861)
NCT ID: NCT04072861
Last Updated: 2025-01-06
Results Overview
Percent Change in Plasma Ferritin From Baseline to 24 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
24 hours post-infusion
Results posted on
2025-01-06
Participant Flow
It was pre-specified to analyze healthy volunteers and participants with CKD Stage 3/Stage 4 together and report results by dose.
Participant milestones
| Measure |
9 mg
Single IV infusion
|
27 mg
Single IV infusion
|
90 mg
Single IV infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
18
|
18
|
|
Overall Study
COMPLETED
|
6
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
9 mg
n=6 Participants
Single IV infusion
|
27 mg
n=18 Participants
Single IV infusion
|
90 mg
n=18 Participants
Single IV infusion
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 11.69 • n=99 Participants
|
59.3 years
STANDARD_DEVIATION 18.50 • n=107 Participants
|
64.3 years
STANDARD_DEVIATION 15.29 • n=206 Participants
|
59.5 years
STANDARD_DEVIATION 17.16 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Weight
|
92.6 kg
STANDARD_DEVIATION 18.79 • n=99 Participants
|
87.2 kg
STANDARD_DEVIATION 16.84 • n=107 Participants
|
88.6 kg
STANDARD_DEVIATION 20.04 • n=206 Participants
|
88.6 kg
STANDARD_DEVIATION 18.18 • n=7 Participants
|
|
Height
|
175.9 cm
STANDARD_DEVIATION 12 • n=99 Participants
|
168.4 cm
STANDARD_DEVIATION 10.11 • n=107 Participants
|
170.3 cm
STANDARD_DEVIATION 8.96 • n=206 Participants
|
170.3 cm
STANDARD_DEVIATION 9.97 • n=7 Participants
|
|
BMI
|
29.8 kg/m2
STANDARD_DEVIATION 3.87 • n=99 Participants
|
30.8 kg/m2
STANDARD_DEVIATION 6.22 • n=107 Participants
|
30.5 kg/m2
STANDARD_DEVIATION 6.71 • n=206 Participants
|
30.5 kg/m2
STANDARD_DEVIATION 6.05 • n=7 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-infusionPopulation: 1 value was missing at the 24 h timepoint from the 90 mg group
Percent Change in Plasma Ferritin From Baseline to 24 hours
Outcome measures
| Measure |
9 mg
n=6 Participants
Single IV infusion
|
27 mg
n=18 Participants
Single IV infusion
|
90 mg
n=17 Participants
Single IV infusion
|
|---|---|---|---|
|
Effect of RBT-9 on Plasma Ferritin Levels
|
-9.83 Percent change from baseline
Interval -34.22 to 14.56
|
7.66 Percent change from baseline
Interval -6.41 to 21.73
|
39.37 Percent change from baseline
Interval 24.96 to 53.77
|
PRIMARY outcome
Timeframe: 24 hours post-infusionPercent Change in Plasma HO-1 From Baseline to 24 hours
Outcome measures
| Measure |
9 mg
n=6 Participants
Single IV infusion
|
27 mg
n=18 Participants
Single IV infusion
|
90 mg
n=18 Participants
Single IV infusion
|
|---|---|---|---|
|
Effect of RBT-9 on Plasma HO-1 Levels
|
-16.07 Percent change from baseline
Interval -68.78 to 36.65
|
10.46 Percent change from baseline
Interval -19.66 to 40.58
|
33.37 Percent change from baseline
Interval 3.12 to 63.62
|
PRIMARY outcome
Timeframe: 24 hours post-infusionPopulation: Values at either baseline and/or the 24 h timepoint were missing from each of the treatment groups
Percent Change in Plasma IL-10 From Baseline to 24 hours
Outcome measures
| Measure |
9 mg
n=3 Participants
Single IV infusion
|
27 mg
n=14 Participants
Single IV infusion
|
90 mg
n=16 Participants
Single IV infusion
|
|---|---|---|---|
|
Effect of RBT-9 on Plasma IL-10 Levels
|
1.07 Percent change from baseline
Interval -304.85 to 306.98
|
153.11 Percent change from baseline
Interval 10.49 to 295.73
|
752.53 Percent change from baseline
Interval 619.11 to 885.94
|
Adverse Events
9 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
27 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
90 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
9 mg
n=6 participants at risk
Single IV infusion
|
27 mg
n=18 participants at risk
Single IV infusion
|
90 mg
n=18 participants at risk
Single IV infusion
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
General disorders
Infusion Site Pain
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
General disorders
Injection Site Bruising
|
0.00%
0/6 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
0.00%
0/18 • 28 days
|
|
General disorders
Peripheral Edema
|
0.00%
0/6 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
11.1%
2/18 • Number of events 2 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Ligament Sprain
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/18 • 28 days
|
0.00%
0/18 • 28 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Glycosuria
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/18 • 28 days
|
0.00%
0/18 • 28 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/6 • 28 days
|
16.7%
3/18 • Number of events 3 • 28 days
|
72.2%
13/18 • Number of events 13 • 28 days
|
|
Vascular disorders
Contusion
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
|
Vascular disorders
Diverticulum Intestinal Hemorrhagic
|
0.00%
0/6 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
0.00%
0/18 • 28 days
|
|
Investigations
Carboxyhaemoglobin Decreased
|
0.00%
0/6 • 28 days
|
0.00%
0/18 • 28 days
|
5.6%
1/18 • Number of events 1 • 28 days
|
Additional Information
Donald J Keyser, Chief Operating Officer
Renibus Therapeutics
Phone: 18178756991
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place