Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9 mg SnPP/240 mg FeS | Experimental |
| |
| 27 mg SnPP/240 mg FeS | Experimental |
| |
| 45 mg SnPP/240 mg FeS | Experimental |
| |
| 63 mg SnPP/240 mg FeS | Experimental |
| |
| 90 mg SnPP/240 mg FeS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBT-1 | Drug | Single intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of RBT-1 on Plasma Ferritin Levels | 24 hours post-infusion | |
| Effect of RBT-1 on Plasma HO-1 Levels | 24 hours post-infusion | |
| Effect of RBT-1 on Plasma IL-10 Levels | 24 hours post-infusion |
Not provided
Not provided
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 estimated glomerular filtration rate (eGFR) between 30-59 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
CKD Stage 4 as determined by eGFR between 15-29 mL/min/1.73 m2 using the CKD-EPI equation.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Clinical Research | Edgewater | Florida | 32141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32291269 | Derived | Zager RA, Johnson ACM, Guillem A, Keyser J, Singh B. A Pharmacologic "Stress Test" for Assessing Select Antioxidant Defenses in Patients with CKD. Clin J Am Soc Nephrol. 2020 May 7;15(5):633-642. doi: 10.2215/CJN.15951219. Epub 2020 Apr 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It was pre-specified to analyze healthy volunteers and participants with CKD Stage 3/Stage 4 together and report results by dose.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 9 mg SnPP/240 mg FeS | Single IV infusion |
| FG001 | 27 mg SnPP/240 mg FeS | Single IV infusion |
| FG002 | 45 mg SnPP/240 mg FeS | Single IV infusion |
| FG003 | 63 mg SnPP/240 mg FeS | Single IV infusion |
| FG004 | 90 mg SnPP/240 mg FeS | Single IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 9 mg SnPP/240 mg FeS | Single IV infusion |
| BG001 | 27 mg SnPP/240 mg FeS | Single IV infusion |
| 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-1 on Plasma Ferritin Levels | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 24 hours post-infusion |
|
28 days
Not provided
Not provided
| 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 SnPP/240 mg FeS | Single IV infusion | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald J Keyser, Chief Operating Officer | Renibus Therapeutics | 18178756991 | jkeyser@renibus.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2020 | Feb 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2019 | Feb 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 |
| 45 mg SnPP/240 mg FeS |
Single IV infusion |
| BG003 | 63 mg SnPP/240 mg FeS | Single IV infusion |
| BG004 | 90 mg SnPP/240 mg FeS | Single IV infusion |
| BG005 | 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/m^2 |
|
Single IV infusion |
| OG004 | 90 mg SnPP/240 mg FeS | Single IV infusion |
|
|
| Primary | Effect of RBT-1 on Plasma HO-1 Levels | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 24 hours post-infusion |
|
|
|
| Primary | Effect of RBT-1 on Plasma IL-10 Levels | 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 |
| 0 |
| 6 |
| EG001 | 27 mg SnPP/240 mg FeS | Single IV infusion | 0 | 18 | 0 | 18 | 6 | 18 |
| EG002 | 45 mg SnPP/240 mg FeS | Single IV infusion | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 63 mg SnPP/240 mg FeS | Single IV infusion | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | 90 mg SnPP/240 mg FeS | Single IV infusion | 0 | 18 | 0 | 18 | 12 | 18 |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Administration site discoloration | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Infusion site reaction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Injection site extravasation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Urine albumin/creatinine ratio increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bacteriuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
Not provided
| 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 |