NCT03893799

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

Completed Phase 1 Results posted Last updated 7 August 2025

What this trial tests

Phase 1 trial testing RBT-1 in Healthy Volunteers in 54 participants. Completed in 31 December 2020.

Timeline

27 August 2019

Primary endpoint
22 April 2020

31 December 2020

Quick facts

Lead sponsor	Renibus Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	54
Start date	27 August 2019
Primary completion	22 April 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• RBT-1 — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →
• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

Renibus Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Healthy Volunteers or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effect of RBT-1 on Plasma Ferritin Levels Primary · 24 hours post-infusion

Group	Value	95% CI
9 mg SnPP/240 mg FeS	592.3	255.2 – 929.3
27 mg SnPP/240 mg FeS	538.8	345.1 – 732.5
45 mg SnPP/240 mg FeS	313.7	-23 – 650.4
63 mg SnPP/240 mg FeS	308.2	-27.6 – 644
90 mg SnPP/240 mg FeS	610.9	417.2 – 804.6

Effect of RBT-1 on Plasma HO-1 Levels Primary · 24 hours post-infusion

Group	Value	95% CI
9 mg SnPP/240 mg FeS	-10.5	-93.2 – 72.2
27 mg SnPP/240 mg FeS	21	-26.7 – 68.7
45 mg SnPP/240 mg FeS	35.4	-47.3 – 118
63 mg SnPP/240 mg FeS	27.7	-55.4 – 110.7
90 mg SnPP/240 mg FeS	44.8	-3.1 – 92.8

Effect of RBT-1 on Plasma IL-10 Levels Primary · 24 hours post-infusion

Group	Value	95% CI
9 mg SnPP/240 mg FeS	66.8	-715.9 – 849.5
27 mg SnPP/240 mg FeS	95.5	-323.5 – 514.5
45 mg SnPP/240 mg FeS	574.6	248.2 – 901.1
63 mg SnPP/240 mg FeS	333.5	-219.2 – 886.2
90 mg SnPP/240 mg FeS	201.4	-117.6 – 520.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

9 mg SnPP/240 mg FeS

Serious: 0/6 (0%)

Deaths: 0/6

27 mg SnPP/240 mg FeS

Serious: 0/18 (0%)

Deaths: 0/18

45 mg SnPP/240 mg FeS

Serious: 0/6 (0%)

Deaths: 0/6

63 mg SnPP/240 mg FeS

Serious: 0/6 (0%)

Deaths: 0/6

90 mg SnPP/240 mg FeS

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (16 terms — click to expand)

Reaction	System	9 mg SnPP/240 mg FeS	27 mg SnPP/240 mg FeS	45 mg SnPP/240 mg FeS	63 mg SnPP/240 mg FeS	90 mg SnPP/240 mg FeS
Photosensitivity reaction	Skin and subcutaneous tissue disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Administration site discoloration	General disorders	—	—	—	—	—
Injection site extravasation	Injury, poisoning and procedural complications	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—
Tenderness	General disorders	—	—	—	—	—
Infusion site reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Hemoglobin decreased	Investigations	—	—	—	—	—
Liver function test increased	Investigations	—	—	—	—	—
Urine albumin/creatinine ratio increased	Investigations	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Bacteriuria	Renal and urinary disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Thrombophlebitis	Vascular disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03893799 adverse events section.

Sponsor's own description

This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Heme Oxygenase 1: A Defensive Mediator in Kidney Diseases.
   Grunenwald A, Roumenina LT, Frimat M. · · 2021 · cited 35× · PMID 33670516 · DOI 10.3390/ijms22042009
2. A Pharmacologic "Stress Test" for Assessing Select Antioxidant Defenses in Patients with CKD.
   Zager RA, Johnson ACM, Guillem A, Keyser J, et al · · 2020 · cited 11× · PMID 32291269 · DOI 10.2215/cjn.15951219
3. The NRF2 stimulating agent, tin protoporphyrin, activates protective cytokine pathways in healthy human subjects and in patients with chronic kidney disease.
   Zager RA, Johnson ACM. · · 2020 · cited 5× · PMID 32940965 · DOI 10.14814/phy2.14566
4. Oxidant- induced preconditioning: A pharmacologic approach for triggering renal 'self defense'.
   Zager RA. · · 2022 · cited 4× · PMID 36305701 · DOI 10.14814/phy2.15507