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

• Sponsor: Renibus Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04072432
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Acute	Drug: RBT-3	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 1b Dose-escalating Study With RBT-3 in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3-4
• Actual Study Start Date: Oct 21, 2018
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Aug 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 120 mg, single IV infusion in healthy volunteers and subjects CKD Stage 3-4	Drug: RBT-3; intravenous administration
Experimental: Cohort 2 240 mg, single IV infusion in healthy volunteers and subjects CKD Stage 3-4	Drug: RBT-3; intravenous administration
Experimental: Cohort 3 360 mg, single IV infusion in healthy volunteers and subjects CKD Stage 3-4	Drug: RBT-3; intravenous administration

Outcome Measures

Primary Outcome Measures

1. Plasma Ferritin [Day 7 post-infusion]

   Effect of RBT-3 on plasma ferritin levels at 7 days post-infusion

2. Urinary Ferritin [Day 7 post-infusion]

   Effect of RBT-3 on urine ferritin levels at 7 days post-infusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).

2. Body weight <125 kg.

3. Able and willing to comply with all study procedures.

4. Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 8 days after study drug administration.

Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 8 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.

1. CKD as determined by estimated glomerular filtration rate (eGFR) between 15-59 ml/min as estimated using the CKD-EPI equation (CKD class 3-4).

Exclusion Criteria:

1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.

2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.

3. Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening.

4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.

5. Any significant acute or chronic diseases, excluding CKD (eGFR ≥15 ml/min).

6. Regular use of drugs of abuse and/or positive findings on urinary drug screening.

7. Current tobacco use and/or positive findings on urinary cotinine screening.

8. 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.

9. 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.

10. Known hypersensitivity or previous anaphylaxis to FeS.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside Clinical Research	Edgewater	Florida	United States	32132

Sponsors and Collaborators

• Renibus Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 5, 2018
• Statistical Analysis Plan - Apr 25, 2019

More Information

Publications

None provided.

• Responsible Party: Renibus Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04072432
• Other Study ID Numbers: REN-002
• First Posted: Aug 28, 2019
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Acute Kidney Injury

Study Results

Participant Flow

Arm/Group Title	120 mg RBT-3	240 mg RBT-3	360 mg RBT-3
Arm/Group Description	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
Period Title: Overall Study
STARTED	6	6	6
COMPLETED	6	6	6
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	120 mg RBT-3	240 mg RBT-3	360 mg RBT-3	Total
Arm/Group Description	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Total of all reporting groups
Overall Participants	6	6	6	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (7.32)	57.7 (14.87)	63.3 (11.83)	60.3 (11.30)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	2 33.3%	4 66.7%	8 44.4%
Male	4 66.7%	4 66.7%	2 33.3%	10 55.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 16.7%	2 33.3%	2 33.3%	5 27.8%
White	5 83.3%	4 66.7%	3 50%	12 66.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 16.7%	1 5.6%

Outcome Measures

1. Primary Outcome

Title	Plasma Ferritin
Description	Effect of RBT-3 on plasma ferritin levels at 7 days post-infusion
Time Frame	Day 7 post-infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	120 mg RBT-3	240 mg RBT-3	360 mg RBT-3
Arm/Group Description	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
Measure Participants	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	108.542 (77.1031)	198.613 (133.0021)	188.646 (26.1344)

2. Primary Outcome

Title	Urinary Ferritin
Description	Effect of RBT-3 on urine ferritin levels at 7 days post-infusion
Time Frame	Day 7 post-infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	120 mg RBT-3	240 mg RBT-3	360 mg RBT-3
Arm/Group Description	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
Measure Participants	6	6	6
Mean (Standard Deviation) [ng/mL]	92.7 (139.28)	3.6 (3.19)	116.9 (159.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	120 mg RBT-3, 240 mg RBT-3, 360 mg RBT-3
	Comments
	Type of Statistical Test	Other
	Comments	Analyses of variance for repeated measures (ANOVA)
Statistical Test of Hypothesis	p-Value	0.05
	Comments	p values were corrected for multiple comparisons by the Bonferroni test if required
	Method	ANOVA
	Comments	ANOVA for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 month
Arm/Group Title	120 mg FeS		240 mg FeS		360 mg FeS
Arm/Group Description	Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4		Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4		Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
All Cause Mortality
	120 mg FeS		240 mg FeS		360 mg FeS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	120 mg FeS		240 mg FeS		360 mg FeS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	120 mg FeS		240 mg FeS		360 mg FeS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		2/6 (33.3%)
Nervous system disorders
Mild Fatigue	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Mild Congestion	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.