Healthy VolunteersPhase 1NCT04072861
A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
A Phase 1 study testing RBT-9 in people with Healthy Volunteers and Chronic Kidney Disease, run by Renibus Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chronic Kidney Disease
- What is being tested?
- RBT-9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2019to 31 Oct 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight <125 kg.
- Able and willing to comply with all study procedures.
- 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.
- CKD stage 3 as determined by a GFR between 30-59 ml/min as estimated using the CKD-EPI equation.
- CKD stage 4 as determined by a GFR between 15-29 ml/min as estimated using the CKD-EPI equation.
Who cannot join
- History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. Cancer free for less than 5 years.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to Screening, whichever was longer.
- Serum ferritin >500 ng/mL or received IV iron within 28 days of Screening.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Any significant acute or chronic diseases, excluding CKD (≥ 15 ml/min); if CKD is present, those not at their baseline of renal function.
- Abnormal Baseline liver tests or hepatitis serologies that suggest active infection.
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- Regular use of drugs of abuse and/or positive findings on urinary drug screening.
- Current tobacco use and/or positive findings on urinary cotinine screening.
- Severely physically or mentally incapacitated and who, in the opinion of Investigator, are unable to perform the subjects' tasks associated with the protocol.
- 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.
- History of photosensitivity or active skin disease which, in the opinion of the Investigator, could increase the risk of photosensitivity.
- Known hypersensitivity or previous anaphylaxis to RBT-9 or tin-based product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside Clinical Research
Edgewater, Florida, 32132
About this study
Official title: A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Being tested
- RBT-9
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBT-9Drug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| 9 mg | Experimental | Not described Receives: Drug: RBT-9 |
| 27 mg | Experimental | Not described Receives: Drug: RBT-9 |
| 90 mg | Experimental | Not described Receives: Drug: RBT-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RBT-9 on Plasma Ferritin Levels
Percent Change in Plasma Ferritin From Baseline to 24 hours
Measured: 24 hours post-infusion
Effect of RBT-9 on Plasma HO-1 Levels
Percent Change in Plasma HO-1 From Baseline to 24 hours
Measured: 24 hours post-infusion
Effect of RBT-9 on Plasma IL-10 Levels
Percent Change in Plasma IL-10 From Baseline to 24 hours
Measured: 24 hours post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 Mar 2019
- Primary completion31 Jul 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072861
- Sponsor's protocol ID
- REN-003
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2019
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4
- ClinicalTrials.gov ID
- NCT04072861
- Acronym / sponsor ID
- REN-003
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 9 mg | Experimental | Drug: RBT-9 |
| 27 mg | Experimental | Drug: RBT-9 |
| 90 mg | Experimental | Drug: RBT-9 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight <125 kg.
- Able and willing to comply with all study procedures.
- 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.
Key exclusion criteria (12 listed)
- History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. Cancer free for less than 5 years.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to Screening, whichever was longer.
- Serum ferritin >500 ng/mL or received IV iron within 28 days of Screening.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Any significant acute or chronic diseases, excluding CKD (≥ 15 ml/min); if CKD is present, those not at their baseline of renal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBT-9intravenous administration | Drug | 27 mg, 9 mg, 90 mg |
Primary outcome
Effect of RBT-9 on Plasma Ferritin Levels
Time frame: 24 hours post-infusion
Percent Change in Plasma Ferritin From Baseline to 24 hours
Effect of RBT-9 on Plasma HO-1 Levels
Time frame: 24 hours post-infusion
Percent Change in Plasma HO-1 From Baseline to 24 hours
Effect of RBT-9 on Plasma IL-10 Levels
Time frame: 24 hours post-infusion
Percent Change in Plasma IL-10 From Baseline to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBT-9 in people with Healthy Volunteers and Chronic Kidney Disease, run by Renibus Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of RBT-9 on Plasma Ferritin Levels (time frame: 24 hours post-infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.