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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893799
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Renibus Therapeutics, Inc.

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

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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


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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893799


Locations
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Renibus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03893799    
Other Study ID Numbers: Clinical Protocol REN-001A
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency