Acute Kidney InjuryPhase 1NCT03630029
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
A Phase 1 study testing FeS and SnPP in people with Acute Kidney Injury, run by Renibus Therapeutics, Inc..
Trial summary
A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-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
- Acute Kidney Injury
- What is being tested?
- FeS and SnPP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2018to 31 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 as determined by estimated glomerular filtration rate (GFR) between 15-45 ml/min as estimated using the CKD-EPI equation (CKD class 3b-4). -
Who cannot join
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
- Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- 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.
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- 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.
- 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.
- Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -
About this study
Official title: A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.
Read the detailed description
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD. The following biomarkers will be used as surrogate measures of protective activity: Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1. Additionally, the P21 biomarker will be monitored at various points of the study.
- Conditions
- Acute Kidney Injury
- Being tested
- FeS and SnPP
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeS and SnPPDrug
Also called FeS (Iron Sucrose) SnPP (Stannous Protoporpyhrin
Escalating doses of drug will be compared for biomarker changes
| Study group | Role | What they receive |
|---|---|---|
| Administer a dose 12mgFeS/9mg SnPP | Other | 12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days. Receives: Drug: FeS and SnPP |
| Administer a dose 60mgFeS/45 mg SnPP | Other | 12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Stannous Protoporphyrin and followed for seven days. Receives: Drug: FeS and SnPP |
| Administer a dose 120mgFeS/90mg SnPP | Other | 12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Stannous Protoporphyrin and followed for seven days. Receives: Drug: FeS and SnPP |
| Administer a dose 180mgFeS/135mg SnPP | Other | 12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days. Receives: Drug: FeS and SnPP |
| Administer a dose of FeS/SnPP CKD Arm | Other | 12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Stannous Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile. The subjects will be followed for seven days. Receives: Drug: FeS and SnPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RBT-1 on biomarkers of cytoprotective activity
Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels
Measured: 7 days
Secondary outcomes (2)
Adverse events
Safety and tolerability of RBT-1 in Healthy Volunteers and subjects with CKD
Measured: 7 days
Establish the optimal dose for future development
The highest dose of RBT-1 with the best safety and tolerability will be determined
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Sep 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: The trial has been enhanced, a new NCT(NCT03893799) listing was created.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 0 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
- NCT03630029
- Sponsor's protocol ID
- REN-001
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 11 May 2020
- Results posted
- No
- 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 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
- ClinicalTrials.gov ID
- NCT03630029
- Acronym / sponsor ID
- REN-001
- Conditions
- Acute Kidney Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial has been enhanced, a new NCT(NCT03893799) listing was created.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.
Detailed description
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD. The following biomarkers will be used as surrogate measures of protective activity: Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1. Additionally, the P21 biomarker will be monitored at various points of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Administer a dose 12mgFeS/9mg SnPP | Other | Drug: FeS and SnPP12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days. |
| Administer a dose 60mgFeS/45 mg SnPP | Other | Drug: FeS and SnPP12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Stannous Protoporphyrin and followed for seven days. |
| Administer a dose 120mgFeS/90mg SnPP | Other | Drug: FeS and SnPP12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Stannous Protoporphyrin and followed for seven days. |
| Administer a dose 180mgFeS/135mg SnPP | Other | Drug: FeS and SnPP12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days. |
| Administer a dose of FeS/SnPP CKD Arm | Other | Drug: FeS and SnPP12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Stannous Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile. The subjects will be followed for seven days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 (9 listed)
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
- Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Regular use of drugs of abuse and/or positive findings on urinary drug screening.
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 |
|---|---|---|
| FeS and SnPPAlso: FeS (Iron Sucrose) SnPP (Stannous ProtoporpyhrinEscalating doses of drug will be compared for biomarker changes | Drug | Administer a dose 120mgFeS/90mg SnPP, Administer a dose 12mgFeS/9mg SnPP, Administer a dose 180mgFeS/135mg SnPP, Administer a dose 60mgFeS/45 mg SnPP, Administer a dose of FeS/SnPP CKD Arm |
Primary outcome
Effect of RBT-1 on biomarkers of cytoprotective activity
Time frame: 7 days
Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels
2 secondary outcomes
Adverse events
Time frame: 7 days
Establish the optimal dose for future development
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FeS and SnPP in people with Acute Kidney Injury, run by Renibus Therapeutics, Inc..
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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-1 on biomarkers of cytoprotective activity (time frame: 7 days). 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 11 May 2020.