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

• ClinicalTrials.gov Identifier: NCT03893799
• Recruitment Status: Completed
• First Posted: March 28, 2019
• Last Update Posted: January 11, 2022
• Sponsor: Renibus Therapeutics, Inc.
• Information provided by (Responsible Party): Renibus Therapeutics, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury	Drug: RBT-1	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 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-1 in Healthy Volunteers and Subjects With Stage 3-4 Chronic Kidney Disease
• Actual Study Start Date: August 27, 2019
• Actual Primary Completion Date: April 22, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1, Healthy Volunteers; Dose A, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 2, Healthy Volunteers; Dose B, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 3, Healthy Volunteers; Dose C, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 4, Subjects with CKD Stage 3; Dose D, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 5, Subjects with CKD Stage 3; Dose E, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 6, Subjects with CKD Stage 4; Dose F, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 7, Subjects with CKD Stage 4; Dose G, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 8, Subjects with CKD Stage 3 or 4; Dose H, single dose	Drug: RBT-1; intravenous administration
Experimental: Cohort 9, Subjects with CKD Stage 3 or 4; Dose I, single dose	Drug: RBT-1; intravenous administration

Outcome Measures

Primary Outcome Measures :

1. Safety and tolerability of RBT-1 [ Time Frame: 28 days ]
   Incidence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 28 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 28 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.

5. CKD Stage 3 as determined by estimated glomerular filtration rate (eGFR) between 30-59 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. CKD Stage 4 as determined by eGFR between 15-29 mL/min/1.73 m2 using the CKD-EPI equation.

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, or currently being treated with oral iron.
4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
5. Any significant acute or chronic diseases.
6. Subjects with abnormal baseline liver tests or hepatitis serologies that suggest active infection.
7. Regular use of drugs of abuse and/or positive findings on urinary drug screening.
8. Current tobacco use and/or positive findings on urinary cotinine screening.
9. 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.
10. 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.
11. Subjects with history of photosensitivity or active skin disease
12. Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof.

Contacts and Locations

Locations

United States, Florida

Riverside Clinical Research

Edgewater, Florida, United States, 32141

Sponsors and Collaborators

Renibus Therapeutics, Inc.

  Study Documents (Full-Text)

Documents provided by Renibus Therapeutics, Inc.:

Study Protocol  [PDF] January 15, 2020

Statistical Analysis Plan  [PDF] October 16, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zager RA, Johnson ACM, Guillem A, Keyser J, Singh B. A Pharmacologic "Stress Test" for Assessing Select Antioxidant Defenses in Patients with CKD. Clin J Am Soc Nephrol. 2020 May 7;15(5):633-642. doi: 10.2215/CJN.15951219. Epub 2020 Apr 14.

• Responsible Party: Renibus Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03893799
• Other Study ID Numbers: Clinical Protocol REN-001A
• First Posted: March 28, 2019
• Last Update Posted: January 11, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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; Acute Kidney Injury; Urologic Diseases; Renal Insufficiency