Trial Outcomes & Findings for A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease (NCT NCT03893799)

NCT ID: NCT03893799

Last Updated: 2025-08-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

54 participants

Primary outcome timeframe

24 hours post-infusion

Results posted on

2025-08-07

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

Participant milestones
Measure	9 mg SnPP/240 mg FeS Single IV infusion	27 mg SnPP/240 mg FeS Single IV infusion	45 mg SnPP/240 mg FeS Single IV infusion	63 mg SnPP/240 mg FeS Single IV infusion	90 mg SnPP/240 mg FeS Single IV infusion
Overall Study STARTED	6	18	6	6	18
Overall Study COMPLETED	6	18	6	6	18
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	9 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	27 mg SnPP/240 mg FeS n=18 Participants Single IV infusion	45 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	63 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	90 mg SnPP/240 mg FeS n=18 Participants Single IV infusion	Total n=54 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 15.75 • n=5 Participants	60.0 years STANDARD_DEVIATION 17.60 • n=7 Participants	72.8 years STANDARD_DEVIATION 4.54 • n=5 Participants	71.8 years STANDARD_DEVIATION 6.34 • n=4 Participants	58.7 years STANDARD_DEVIATION 20.08 • n=21 Participants	61.0 years STANDARD_DEVIATION 17.54 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	22 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants	32 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	15 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants	50 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	14 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants	36 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Weight	93.3 kg STANDARD_DEVIATION 16.37 • n=5 Participants	90.3 kg STANDARD_DEVIATION 16.8 • n=7 Participants	92.9 kg STANDARD_DEVIATION 17.2 • n=5 Participants	88.4 kg STANDARD_DEVIATION 17.18 • n=4 Participants	82.9 kg STANDARD_DEVIATION 15.69 • n=21 Participants	88.2 kg STANDARD_DEVIATION 16.34 • n=8 Participants
Height	180.9 cm STANDARD_DEVIATION 7.27 • n=5 Participants	167.6 cm STANDARD_DEVIATION 9.26 • n=7 Participants	166.4 cm STANDARD_DEVIATION 6.93 • n=5 Participants	170.3 cm STANDARD_DEVIATION 7.41 • n=4 Participants	168.5 cm STANDARD_DEVIATION 6.93 • n=21 Participants	169.5 cm STANDARD_DEVIATION 8.66 • n=8 Participants
BMI	28.5 kg/m^2 STANDARD_DEVIATION 4.61 • n=5 Participants	32.3 kg/m^2 STANDARD_DEVIATION 6.61 • n=7 Participants	33.4 kg/m^2 STANDARD_DEVIATION 4.77 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 7.24 • n=4 Participants	29.2 kg/m^2 STANDARD_DEVIATION 5.63 • n=21 Participants	30.8 kg/m^2 STANDARD_DEVIATION 6.02 • n=8 Participants

PRIMARY outcome

Timeframe: 24 hours post-infusion

Outcome measures

Outcome measures
Measure	9 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	27 mg SnPP/240 mg FeS n=18 Participants Single IV infusion	45 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	63 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	90 mg SnPP/240 mg FeS n=18 Participants Single IV infusion
Effect of RBT-1 on Plasma Ferritin Levels	592.3 Percent change from baseline Interval 255.2 to 929.3	538.8 Percent change from baseline Interval 345.1 to 732.5	313.7 Percent change from baseline Interval -23.0 to 650.4	308.2 Percent change from baseline Interval -27.6 to 644.0	610.9 Percent change from baseline Interval 417.2 to 804.6

PRIMARY outcome

Timeframe: 24 hours post-infusion

Outcome measures

Outcome measures
Measure	9 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	27 mg SnPP/240 mg FeS n=18 Participants Single IV infusion	45 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	63 mg SnPP/240 mg FeS n=6 Participants Single IV infusion	90 mg SnPP/240 mg FeS n=18 Participants Single IV infusion
Effect of RBT-1 on Plasma HO-1 Levels	-10.5 Percent change from baseline Interval -93.2 to 72.2	21 Percent change from baseline Interval -26.7 to 68.7	35.4 Percent change from baseline Interval -47.3 to 118.0	27.7 Percent change from baseline Interval -55.4 to 110.7	44.8 Percent change from baseline Interval -3.1 to 92.8

PRIMARY outcome

Timeframe: 24 hours post-infusion

Population: Values at either baseline and/or the 24 h timepoint were missing from each of the treatment groups