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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04072432
Other study ID # REN-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 21, 2018
Est. completion date August 26, 2019

Study information

Verified date December 2021
Source Renibus Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date August 26, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
RBT-3
intravenous administration

Locations

Country Name City State
United States Riverside Clinical Research Edgewater Florida

Sponsors (1)

Lead Sponsor Collaborator
Renibus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Ferritin Effect of RBT-3 on plasma ferritin levels 24 hours post-infusion 24 hours post-infusion
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