Phase 1
N=18
A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Healthy Volunteers · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT04072432 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Effect of RBT-3 on Plasma Ferritin Levels — 2.49; 4.42; 4.90 Ratio (24 h post-infusion over baseline)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RBT-3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Renibus Therapeutics, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of RBT-3 on Plasma Ferritin Levels |
2.49; 4.42; 4.90 | — |
| PRIMARY Effect of RBT-3 on Plasma HO-1 Levels |
0.0171; -0.7086; -0.0641 | — |
Summary
This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight 500 ng/ml or who have received IV iron within 28 days of screening.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Any significant acute or chronic diseases, excluding CKD (eGFR ≥15 ml/min).
- Regular use of drugs of abuse and/or positive findings on urinary drug screening.
- Current tobacco use and/or positive findings on urinary cotinine screening.
- Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.
- Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- Known hypersensitivity or previous anaphylaxis to FeS.
Data sourced from ClinicalTrials.gov (NCT04072432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.