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

NCT ID: NCT04072432

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-21
• Study Completion Date: 2019-08-26

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.

Conditions

Healthy Volunteers; Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

120 mg

Group Type: EXPERIMENTAL

RBT-3

Intervention Type: DRUG

intravenous administration

240 mg

Group Type: EXPERIMENTAL

RBT-3

Intervention Type: DRUG

intravenous administration

360 mg

Group Type: EXPERIMENTAL

RBT-3

Intervention Type: DRUG

intravenous administration

Interventions

RBT-3

intravenous administration

Intervention Type: DRUG

Eligibility 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 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.

5. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Renibus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Riverside Clinical Research

Edgewater, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REN-002

Identifier Type: -

Identifier Source: org_study_id