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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9 mg | Experimental |
| |
| 27 mg | Experimental |
| |
| 90 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBT-9 | Drug | intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of RBT-9 on Plasma Ferritin Levels | Percent Change in Plasma Ferritin From Baseline to 24 hours | 24 hours post-infusion |
| Effect of RBT-9 on Plasma HO-1 Levels | Percent Change in Plasma HO-1 From Baseline to 24 hours | 24 hours post-infusion |
| Effect of RBT-9 on Plasma IL-10 Levels | Percent Change in Plasma IL-10 From Baseline to 24 hours | 24 hours post-infusion |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
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It was pre-specified to analyze healthy volunteers and participants with CKD Stage 3/Stage 4 together and report results by dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | 9 mg | Single IV infusion |
| FG001 | 27 mg | Single IV infusion |
| FG002 | 90 mg | Single IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 9 mg | Single IV infusion |
| BG001 | 27 mg | Single IV infusion |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of RBT-9 on Plasma Ferritin Levels | Percent Change in Plasma Ferritin From Baseline to 24 hours | 1 value was missing at the 24 h timepoint from the 90 mg group | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 24 hours post-infusion |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 9 mg | Single IV infusion | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald J Keyser, Chief Operating Officer | Renibus Therapeutics | 18178756991 | jkeyser@renibus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2019 | Feb 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2019 | Feb 1, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C032628 | tin protoporphyrin IX |
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| 90 mg |
Single IV infusion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
|
|
| Primary | Effect of RBT-9 on Plasma HO-1 Levels | Percent Change in Plasma HO-1 From Baseline to 24 hours | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 24 hours post-infusion |
|
|
|
| Primary | Effect of RBT-9 on Plasma IL-10 Levels | Percent Change in Plasma IL-10 From Baseline to 24 hours | Values at either baseline and/or the 24 h timepoint were missing from each of the treatment groups | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 24 hours post-infusion |
|
|
|
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 27 mg | Single IV infusion | 0 | 18 | 0 | 18 | 4 | 18 |
| EG002 | 90 mg | Single IV infusion | 0 | 18 | 0 | 18 | 14 | 18 |
| Diarrhea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Infusion Site Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Peripheral Edema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ligament Sprain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Contusion | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Diverticulum Intestinal Hemorrhagic | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Carboxyhaemoglobin Decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |